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EINSTEIN HEALTHCARE NETWORK CANCER CENTER

ACTIVE CLINICAL TRIALS

TABLE OF CONTENTS

PAGE Studies by Organ/System

3 Brain

4 - 6 Breast – Neoadjuvant/Adjuvant

6 Breast – Advanced/Metastatic

7-8 Gastrointestinal – Colorectal – Adjuvant

9 Gastrointestinal –Advanced, Metastatic 10 Gastrointestinal –Hepatocellular

11 Gastrointestinal –Pancreatic

12-13 Genitourinary – Prostate

14 Gynecological

15-16 Head and Neck

17 Myeloma

18-20 Lung – NSCLC

21-22 Lung – SCLC/Thymoma, Thymic Carcinoma/Mesothelioma

23-24 Supportive care

25 Multiple cancer diagnoses

26 Trials pending activation

27 ECOG Path. Coordinating Ctr Information “NEW” 10/24/2014

BRAIN PROTOCOL CONTACTS

Radiation Oncology Investigator – Kenneth Zeitzer, MD 215-456-6280 Coordinator – Jeff Mealey, RN 215-456-6316

No active studies at this time.

BREAST PROTOCOL CONTACTS

MEDICAL ONCOLOGY Investigator – Mark S. Morginstin, DO 215-456-3880 Coordinator – Joann R. Ackler, RN, OCN, CCRP 215-456-8295

RADIATION ONCOLOGY Investigator – Angelica T. Montesano, MD 215-456-6280 Coordinator – Jeff Mealy, RN 215-456-6316

STUDY# TITLE and ELIGIBILITY CRITERIA THERAPY ADJUVANT NRG BR-003/ A Randomized Phase III Trial of Adjuvant Therapy Arm 1: CIRB-005 Comparing Doxorubicin Plus Cyclophosphamide Followed by Doxorubicin 60 mg/M2 IV Weekly Paclitaxel with or without Carboplatin for Node- Cyclophosphamide 600 mg/m2 IV # Pts: _____ Positive or High-Risk Node Negative Invasive Breast Cancer Q 2 Weeks X 4 cycles Eligibility: Unilateral breast IDC: pT1-3; pN0 – pN3b, Followed by: underwent mastectomy or clear margins on lumpectomy/re- Paclitaxel 80 mg/m2 IV weekly x 12 doses excision; ER, PR, & HER2 negative (please see pgs. 14-15 of protocol for specifics). < 60 days from last surgery to Arm 2: randomization. Adequate organ function/lab values (see pgs. 15 Doxorubicin 60 mg/M2 IV & 16 of protocol); Please refer to section 3.3, pgs. 16 & 17 for Cyclophosphamide 600 mg/m2 IV exclusion criteria details. Initial approval 3/21/2016 Q 2 Weeks X 4 cycles Followed by: CIRB Approval expires 2/17/17 Paclitaxel 80 mg/m2 IV weekly x 12 doses and Carboplatin AUC 5 IV Q 3 weeks

STUDY# TITLE and ELIGIBILITY CRITERIA THERAPY ADJUVANT RTOG 1014 Partial Breast Re-Irradiation (PBrI) Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 3D-Conformal External Beam A Phase II study of Repeat 1.5 GY x 15 (BID) to 45 Gy Total 1.5 GY x 15 (BID) to 45 Gy Total Breast Preserving Surgery and Patient Population: 3D-Conformal � Histopathologic confirmation via lumpectomy of local in-breast Partial Breast Re-Irradiation ipsilateral recurrence (PBrI) for Local Recurrence of � Final breast surgery (lumpectomy and/or final re-excision) within Breast Carcinoma 42 days prior to study entry; � Initial lumpectomy followed by whole breast radiation >1 year Closed to accrual 6/18/13 prior to study entry; � Ipsilateral breast mammogram and MRI within 120 days prior to study entry. Contralateral breast mammogram within 12 months of study entry. � Negative histologic margins of resection, no tumor on ink, following breast-preserving surgery of local recurrence.

RTOG 1005 Patient Population: ARM 1: Standard fractionation pStage 0, I, II Breast Cancer resected by lumpectomy Whole Breast 50.0 Gy/25 fractions/2.0 Gy daily ypStage 0, I,II Breast Cancer resected by lumpectomy that Optional fractionation of 42.7Gy in 16 fractions permissible A PHASE III TRIAL OF followed neoadjuvant systemic therapy Sequential Boost 12.Gy/6 fractions/2.0 Gy daily or ACCELERATED WBI WITH 14.0Gy/7fractions/2Gy daily HYPOFRACTIONATION PLUS ARM 2: Hypofractionation (15 fractions total) CONCURRENT BOOST Whole Breast 40 Gy/15 fractions/2.67 Gy daily Vs. STANDARD WBI Concurrent boost 48.0 Gy/3.2 Gy daily PLUS SEQUENTIAL BOOST FOR EARLY-STAGE BREAST CANCER

BREAST – Advanced/Metastatic E2112 A Randomized Phase III Trial of Endocrine Therapy plus Arm A: CIRB-004 Entinostat/Placebo in Postmenopausal Patients with Exemestane 25 mg PO daily x 28 days Hormone Receptor-Positive Advanced Breast Cancer Entinostat 5 mg PO days 1, 8, 15, & 22 # Pts. = _____ Eligibility:ER or PR (+) hist. confirmed adeno ca; must be HER2 Arm B: Initial NCI-CIRB AEHN approval 2/4/2016 neg.; Stage III/locally advanced or metastatic not suitable for Exemestane 25 mg PO daily x 28 days therapy of curative intent. Meas or non-meas disease evaluated < Placebo 5 mg PO days 1, 8, 15, & 22 Expires May 20, 2016 4 wks. Please see eligibility checklist for complete entry criteria [protocol section 3.1, pages 19-22]. A cycle = 28 days

GI PROTOCOL CONTACTS – ANAL, COLORECTAL, ESOPHAGEAL, GASTRIC, HEPATOCELLULAR, PANCREATIC, & GIST

Medical Oncology: Investigator – John Leighton, MD 215-456-3880 Coordinator – Joann R. Ackler, RN, OCN, CCRP 215-456-8295

Radiation Oncology: Investigator – Kenneth Zeitzer, MD 215-456-6285 Coordinator – Jeff Mealy, RN 215-456-6316

GASTROINTESTINAL STUDIES – Esophagus & Gastric – No active studies at this time.

GASTROINTESTINAL – Adjuvant/Resected Colon

C80702 Phase III Trial of 6 vs. 12 Treatments of Adjuvant Folfox + Arm A: 6 cycles FOLFOX* + Celecoxib/placebo Stage III Celecoxib/Placebo for Patients with Resected Stage III Colon (400 mg daily) Q 2 weeks Cancer (H) N-4285 Arm B: 12 cycles FOLFOX* + Eligibility: Hist. proven Adenocarcinoma; margin > 12 cm from Celecoxib/placebo (400 mg daily) Q 2 weeks # Pts. 5 anal verge & completely resected – R0 resection must be in Accrual goal = 10 / 2,500 operative report; > 1 + lymph node or N1C [see AJCC v. 7]; *Oxaliplatin – 85 mg/m2 IV over 2 hrs, followed synchronous colon primaries OK; PS 0-2; adequate hematologic, by Study Nurse: Joann Ackler renal, & hepatic function; NO -- evidence of residual nodal or *Leucovorin 400 mg/m2 IV over 2 hrs, followed metastatic disease; NSAIDS or ASA use > 3 x/wk; prior or by Closed to accrual concurrent malignancy except in situ skin cancer unless NED > 5 *5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 11.20.15 yrs; neuro-toxicity > Gr 2; history UGI ulcers, bleed, or CIV over 46-48 hrs. perforation x 3yrs; uncontrolled HTN, unstable angina, any history Update #7 approved 3/16/2015 of MI or CVA, NYHA class III/IV CHF; allergy to sulfonamides, NOTE: Treatment must begin > 21 and < 56 IRB Approval Expires celecoxib, NSAIDS. days after definitive resection. September 17, 2016

GASTROINTESTINAL – Metastatic Colorectal

STUDY# TITLE and ELIGIBILITY CRITERIA THERAPY

2012-PT023-V3.4 Phase III Double-Blinded, Placebo Controlled Study of Study drug (MABp1/placebo) WIRB # 20120762 XilonixTM for Improving Survival in Metastatic Colorectal 7.5 mg/kg IV over 1 hour (+/- 15 minutes) Cancer Patients with Cachexia Q 2 weeks # Pts. =1 (under v2.4); 3 (under v3.4) 1 hour observation will follow each infusion Eligibility: Path. Confirmed metastatic or unresectable, refractory colon cancer (refer to protocol pg 30 for required prior therapies);

PS = 0-2; Weight loss in past 6 months must be < 20%; most *all subjects will receive BSC (best supportive care) Total = 4 recent anti-cancer therapy must be > 2; adequate organ function – Accrual goal = 8 / 650 + ++ see specific lab parameters pg 29; serum K & Mg levels must be WNL – OK to replenish to normal prior to enrollment; refer to Study nurse: Joann Ackler pg 31 for specific cardiac status criteria; NO active infections, HIV, Hepatitis B or C; NO TB history (latent or active) or + IGRA; AEs from prior trt must be < grade 1. Restricted therapies:at least 2 weeks since last therapy WIRB Initial Approval Date – including; XRT, chemotherapy, immunotherapy, surgery, 5.13.2013, hormonal therapy or targeted biologics; at least 4 weeks since Version 3.4 -9.22.2015 agents that target IL-1/TNF-alpha. Expires 5.17.2016

GASTROINTESTINAL STUDIES –HEPATOCELLULAR – No active trials effective 11/19/2014

STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

GASTROINTESTINAL STUDIES-PANCREATIC STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY RTOG 0848 A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Ist Randomization Treatment for Patients with Resected Head of Pancreas Adenocarcinoma Arm 1: gemcitabine x 5 cycles Arm 2: gemcitabine + erlotinib x 5 cycles

Primary head of pancreas invasive adenocarcinoma resected (i.e., removal of Evaluate to confirm no progression Study Nurse: all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a 2nd Randomization pylorus preserving pancreaticoduodenectomy; IPMN are eligible; T1-3, N0-1, Arm 3: 1 cycle same chemotherapy as first M-0 eligible. randomization treatment arm Arm 4: 1 cycle same chemotherapy as first randomization treatment arm followed by XRT + capecitabine or 5-FU

GU PROTOCOL CONTACTS- Bladder, Prostate, Renal

RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280 Coordinator – Jeff Mealey, RN 215-456-6316

ECOG/Other: Investigator – William Tester, MD 215-456-3880 Coordinator – Joann Ackler RN, OCN 215-456-8295

Prostate STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

RTOG 0534 A PHASE III TRIAL OF SHORT TERM ANDROGEN Arm 1: PBRT alone PBRT 64.8-70.2 Gy DEPRIVATION WITH PELVIC LYMPH NODE OR PROSTATE BED ONLY RADIOTHERAPY (SPPORT) IN PROSTATE Arm 2: PBRT + NC-STAD PBRT 64.8-70.2 Gy + NC-STAD CANCER for 4-6 months, beginning 2 months before RT PATIENTS WITH A RISING PSA AFTER RADICAL PROSTATECTOMY Arm 3: PLNRT + PBRT + NC-STAD PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy, Lymph node negative adenocarcinoma of the prostate treated with NC-STAD for 4-6 months, beginning 2 months before RT radical prostatectomy Post-radical prostatectomy PSA of ≥ 0.1 - < 2.0 ng/mL; pathologic T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a positive prostatectomy surgical margin; Gleason ≤ 9

RTOG 0938 A Randomized Phase II Trial Of Hypofractionated Radiotherapy For Treatment techniques/machine Favorable Risk Prostate Cancer-RTOG CCOP Study 1. All linear accelerator based treatment (excluding Cyberknife) Histologically confirmed diagnosis of adenocarcinoma of the 2. Cyberknife prostate within 180 days of randomization; Gleason 3. Protons scores 2-6; Clinical stage T1-2a; PSA < 10 ng/mL (PSA should not Arm 1 be obtained within 10 days after prostate 36.25 Gy in 5 fractions of 7.25 Gy over two biopsy). and a half weeks (in 15-17 days)* Arm 2 51.6 Gy in 12 daily fractions of 4.3 Gy over two and a half weeks (in 16-18 days)* RTOG 0815 H(N) A Phase III Prospective Randomized Trial Of Dose-Escalated Stratify by Number of Risk Factors; Comorbidity Status; RT Radiotherapy With Or Without Short-Term Androgen Deprivation Modality Study Nurse: Jeff Mealey, RN Therapy For Patients With Intermediate-Risk Prostate Cancer Arm 1: Dose-escalated RT alone

Intermediate risk for recurrence as determined by having one or Arm 2: Dose-escalated RT combined with short-term (6 more of the following: Gleason Score 7; PSA >10 but <20; Clinical months) androgen blockade (LHRH agonist + antiandrogen) Stage T2b-T2c. Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration, except as noted in protocol Section 3.1.2. No evidence of bone metastases (M0) on bone scan

GYNECOLOGIC

PROTOCOL CONTACTS RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280 Coordinator – Jeff Mealey, RN 215-456-6316

CTSU/GOG/OTHER: Investigator – Claudia Dourado, MD 215-456-3880 Coordinator –

No Active Studies at this time

GYN- CERVICAL STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

No Active Studies at this time

GYN-ENDOMETRIAL/PERITONEAL/OVARIAN

STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

Head & Neck Studies-

RADIATION ONCOLOGY Investigator: Kenneth Zeitzer, MD 215-456-6280 Coordinator: Jeff Mealey, RN 215-456-6316

HEAD & NECK STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

RTOG 0920 A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Arm 1: Radiation Therapy Alone, 2 Gy/day, in Locally-Advanced Resected Head and Neck Cancer 30 fractions for a total of 60 Gy*

Arm 2: Radiation Therapy + Cetuximab Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma,  At least 5 days prior to RT: Cetuximab: carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx); 2 Clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant metastases; Initial dose, 400 mg/m Gross total resection of the primary tumor with curative intent must be completed  RT: 2 Gy/day in 30 fractions for a total within 7 weeks of registration with surgical pathology demonstrating one or of 60 Gy* plus cetuximab, 250 more of the following "intermediate" risk factors: mg/m2/week x 6 weeks

 Perineural invasion;  plus cetuximab: 250 mg/m2/week x 4 weeks post-RT

 Lymphovascular invasion; *IMRT is mandatory. Dose is 60 Gy prescribed to at least 95% of the PTV. If  Single lymph node > 3 cm or > 2 lymph nodes (all < 6 cm) [no IGRT is used, it should be daily to assure that extracapsular extension]; error/variance is < 3.5 mm. Note: 66 Gy is  Close margin(s) of resection, defined as cancer extending to within 5 permitted and optional. mm of a surgical margin;

 T3 or microscopic T4a primary tumor (Note: Gross T4a or T4b is ineligible);

 T2 oral cavity cancer with > 5 mm depth of invasion.

STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY RTOG 1016 Phase III Trial of Radiotherapy Plus Cetuximab Versus Arm 1: Chemoradiotherapy in HPV-Associated Oropharynx Cancer Accelerated IMRT, 70 Gy for 6 weeks Patients must be positive for p16, determined by the Innovation Center + high dose DDP (100 mg/m2) Days 1 and 22 CLIA lab at The Ohio (Total: 200 mg/m2) State University (OSU) prior to Step 2 registration (randomization); see 10.2 for details of Arm 2: tissue submission. Patients must consent to submission of tissue for this analysis. Patients also Accelerated IMRT, 70 Gy for 6 weeks must consent to provide their smoking history by completing that portion of the + 8 doses of cetuximab (400 mg/m2) loading computer-assisted self dose pre-IMRT, 250 mg/m2 weekly during interview (CASI) head and neck risk factor survey tool. IMRT,and for 1 week after IMRT) For this study, IMRT is mandatory. IGRT credentialing is mandatory when using PTV margins < 5 mm. See Section 5.0 for required pre-registration credentialing for IMRT (and for IGRT, if used for margin reduction). Patient Population: (See Section 3.0 for Eligibility) Squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); stage T1-2, N2a-3, or T3-4 any N; patient tumor must be p16 positive

HEMATOLOGIC PROTOCOL CONTACTS

MULTIPLE MYELOMA

PROTOCOL CONTACTS RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280 Coordinator – 215-456-6316

CTSU/ECOG/OTHER: Investigator – Gabor Varadi, MD 215-456-3880 Coordinator – Joann Ackler, RN OCN 215-456-8295

No Active Studies at this time

LUNG PROTOCOL CONTACTS NSCLC, SCLC

RTOG: Investigator – Kenneth Zeitzer, MD 215-456-6280 Coordinator – Jeffrey Mealey, RN 215-456-6316

ECOG/Others: Investigators – William Tester, MD 215-456-3880 John Leighton, MD 215-827-1570 Coordinators – Joann Ackler RN, OCN, CCRP 215-456-8295

LUNG – NSCLC: Adjuvant

STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY A151216/ALCHEMIST Adjuvant Lung Cancer Enrichment Marker Identification and If no adjuvant therapy, register patient < 75 days following surgery CIRB-001 Sequencing Trial (ALCHEMIST) If adjuvant chemo. Only, register patient < 165 days following surgery Main Study Eligibility: Completely resected stage IB (> 4cm), II or IIIA non- # Pts. = ___ squamous NSCLC; adequate FFPE tissue available for central EGFR and If adjuvant combination chemo-xrt, register patient < 225 days following surgery. ALK genotyping – Section 3.1, pages 7-8; PS = 0-1; NO neo-adjuvant NCI-CIRB Approval therapy for this lung cancer; NO prior treatment targeting EGFR or ALK; Expires: 11/18/2016 NO second primary lung cancer (considered concurrent malignancy).

A081105/Erlotinib Sub-study Randomized Double Blind Placebo Controlled Study of Erlotinib or Erlotinib/placebo 150 mg/day to ALCHEMIST Placebo in Patients with Completely Resected Epidermal Growth CIRB-002 Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer 1 cycle = 21 days (NSCLC) Duration = up to 2 years if no recurrence or excessive toxicity # Pts. = ___ Eligibility: Previously registered to ALCHEMIST w/EGFRexon 19 deletion or L858R mutation; Only prior in situ carcinomas or non- NCI-CIRB Approval melanoma skin cancers allowed; NO history of cornea abnormalities Expires: 11/18/2016 See protocol pages 11-12 for complete list of entry criteria & time to randomization E4512/ Crizotinib Sub-study A Phase III Double-Blind Trial for Surgically Resected Early Stage Crizotinib/placebo 250 mg PO BID (Twice a day) to ALCHEMIST Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients CIRB-003 with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) 1 cycle = 21 days Fusion Protein Duration = up to 2 years if no recurrence or excessive toxicity # Pts. = ___ Eligibility: Previously registered to ALCHEMIST; EML4-ALK fusion gene positive; NO known interstitial fibrosis or interstitial lung disease; NCI-CIRB Approval NO use of substances that are potent CYP3A4 inhibitors or inducers (see Expires: 6/3/2016 Appendix V). See protocol pages 13 -17 for complete entry criteria.

Locally Advanced STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY RTOG 0839 RANDOMIZED PHASE II STUDY OF PRE-OPERATIVE Randomize: CHEMORADIOTHERAPY +/- PANITUMUMAB FOLLOWED Arm 1: Induction Chemoradiation BY Paclitaxel & Carboplatin: 1x/week for 6 weeks CONSOLIDATION CHEMOTHERAPY IN POTENTIALLY Concurrent RT: 2 Gy/day, 5x/week, for 6 weeks, for a total of 60 OPERABLE LOCALLY Gy ADVANCED (STAGE IIIA, N2+) NON-SMALL CELL LUNG CANCER Arm 2: Induction Chemoradiation and Panitumumab Panitumumab 1x/week for 6 weeks Pathologically proven diagnosis Stage IIIA (T1-T3) with a Paclitaxel & Carboplatin: 1x/week for 6 weeks single primary lung parenchymal lesion and N2 positive Concurrent RT: 2 Gy/day, 5x/week, for 6 weeks, for a total of 60 ipsilateral mediastinal nodes Gy

All Patients Reassessment 4 weeks after Induction treatment Resectable Patients with No Disease Progression Surgery within 2 weeks of reassessment and within 6 weeks of completion of induction treatment

Inoperable Patients (inoperable for medical, anatomical, or other reasons) with No Disease Progression Patient proceeds to consolidation treatment within 6 weeks of completion of induction treatment Arms 1 and 2: Consolidation Chemotherapy Paclitaxel & Carboplatin: q21 days x 2 RTOG 0813 SEAMLESS PHASE I/II STUDY OF STEREOTACTIC LUNG Escalating dose levels; at all levels, patients will receive q 2 day RADIOTHERAPY (SBRT) FOR EARLY STAGE, CENTRALLY fractionation X 5 fractions over 1.5-2 weeks LOCATED, NON-SMALL CELL LUNG CANCER (NSCLC) IN MEDICALLY INOPERABLE PATIENTS

Patients with stage T1-2, N0, M0, non-small cell lung cancer, tumor size ≤ 5 cm, who are not candidates for a complete surgical resection in the opinion of a thoracic surgeon; only patients with tumors within or touching the zone of the proximal bronchial tree or adjacent to mediastinal or pericardial pleura.

LUNG – NSCLC: Advanced/Metastatic (continued) 20

STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

E5508 Randomized Phase III Study of Maintenance Therapy with Induction: NSCLC Stage IV, 1st Line Bevacizumab, Pemetrexed, or a combination of Bev + Pemetrexed Paclitaxel 200 mg/m2 IV + Following Carboplatin, Paclitaxel & Bevacizumab for Advanced Carboplatin AUC 6 IV + (H) N-4269 NSCLC Bevacizumab 15 mg/kg IV Study Nurse: Joann Ackler Q 3 weeks X 4 cycles NSCLC (non-squamous); Stage IV [M1a & M1b or recurrent); PS # Pts: 14 = 0-1; Prior adjuvant chemo OK if > 12 months prior to study – Maintenance: Accrual goal = 20 / 1495 NO prior use of paclitaxel, pemetrexed, or bevacizumab; Randomized if SD or PR: NO prior chemo for advanced NSCLC; NO hemoptysis < 4 Arm A: Bevacizumab 15 mg/kg IV Addendum #10 approved 10/21/14 wks (1/2 tsp.); NO cavitary lung lesions; Treated brain Arm B: Pemetrexed 500 mg/M2 IV Administrative changes only metastases OK per amendment #7; Prior XRT OK if > 3 wks. Arm C: Bev plus Pem 500 mg/M2 IV Notice: Step 1 registration closed prior to study; adequate heme., renal, & hepatic function; BP Q 3 weeks until PD to accrual 5.8.15 <150/100 @ baseline; NO history of thrombotic or bleeding IRB Approval expires disorders < 12 months. NO pre-menopausal women. See May 14, 2016 eligibility checklist for complete list of bevacizumab-related criteria. M14-359 (AbbVie) Randomized, Open-label. Multicenter, Phase III Trial Comparing Veliparib (ABT-888): 120 mg BID Veliparib Plus Carboplatin and Paclitaxel versus Investigator’s Days -2 thru 5 HN-4708 Choice of Standard Chemotherapy in Subjects Receiving First Study Nurse: Joann Ackler Cytoxic Chermotherapy for Metastatic or Advanced Non-squamous Reference (Investigator’s choice) therapy x 6 NSCLC and who are current or former smokers* cycles # Pts:_____ Eligibility: NSCLC – hist/cyt. confirmed & at least predominantly Carboplatin: AUC 6 Day 1 Accrual goal = 10 / 525 non-squamous; Must know EGFR/ALK status: if EGFR mutated Paclitaxel: 200 mg/m2 Day 1 or with ALK gene rearrangement, must have progressed after 1st Pemetrexed: 500 mg/m2 Amendment 3 approved9.4.15; line targeted therapy. > 1 meas. Lesion by RECIST; PS 0-1; Cisplatin: 75 mg/m2 additional ICF language approved adequate organ function – see lab criteria, protocol page 6; NO: 11.20.15 peripheral neuropathy > gr.2, NO CNS mets NO seizures < 12 Maintenance Pemetrexed if suitable months before study entry; NO prior trt for NSCLC except neo- IRB approval expires adj. or adjuvant therapy > 12months before study entry. Any ext. 1 cycle = 21 days December 27, 2016 beam RT [thoracic] must be completed by 4 weeks or if to bone by 2 weeks before study entry. NO prior treatment with a PARP inhibitor. NO hist. of other cancer < 3years except in situ cancers considered cured.

*Defined as currently smoking –or- > 100 smoking events lifetime and not smoked in past 12 months

LUNG- SCLC –Limited Stage STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY RTOG 0538 PHASE III COMPARISON OF THORACIC Schema (1 cycle = 21 days) CALGB 30610 RADIOTHERAPY REGIMENS IN PATIENTS WITH Patients will receive 4 cycles of chemotherapy on all arms LIMITED SMALL CELL LUNG CANCER ALSO Part I: RECEIVING CISPLATIN AND ETOPOSIDE Arm A: Radiotherapy (every day, Monday-Friday, for a total of 3 weeks) XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks No prior chemotherapy or radiotherapy for SCLC. Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks) No prior mediastinal or thoracic radiotherapy Cisplatin 80 mg/m2 IV on day 1, every 21 days Patients with complete surgical resection of disease are not Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days eligible. Arm B: Radiotherapy (every day, Monday-Friday, for a total of 7 weeks) XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks) Cisplatin 80 mg/m2 IV on day 1, every 21 days Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days Arm C: Radiotherapy (every day, Monday-Friday, for a total of 5 weeks) XRT: 61.2 Gy Concomitant boost: QD (1.8 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 16 days of treatment; then BID (1.8 Gy/fx) for 9 days of treatment Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks) Cisplatin 80 mg/m2 IV on day 1, every 21 days Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days Prophylactic cranial irradiation (PCI) should be offered to all patients with a complete or near complete response (see Section 8.2.9 for further details).

Part II: Based on the results of Part I, the experimental arm with the higher rate of toxic events will be discontinued and patients will be randomized as follows: Arm A: Radiotherapy (every day, Monday-Friday, for a total of 3 weeks) XRT: 45 Gy BID (1.5 Gy/fx) for 3 weeks, starting on day 1 of Cycle 1 or 2 Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks) Cisplatin 80 mg/m2 IV on day 1, every 21 days Etoposide 100 mg/m2 IV over 60-120 minutes on days 1, 2, and Register/ 3, every 21 days Arm B or C, depending on which arm is less toxic.

Prophylactic cranial irradiation (PCI) should be offered to all patients with a complete or near complete response (see Section 8.2.9 for further details).

LUNG –Small Cell Extensive Stage – No active studies at this time STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

Supportive Care/Observational Studies STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY Incyte INCB-MA-PV-401 PROSPECTIVE OBSERVATIONAL STUDYOF PATIENTS No intervention per protocol - P. Vera Observational Study WITH POLYCYTHEMIA VERA IN US CLINICAL Observational clinical data collection HN-4662 EXP PRACTICES (REVEAL) Questionnaires: baseline & Q 3 months x 3-4 yrs. # Patients = 14 Accrual goal = 27/2,000 Eligibility: PV diagnosis, receiving care including, not ltd to: Optional blood sampling annually x 3-4 yrs. PI – Dr. Goldstein surveillance, ASA (> 81 mg), antithrombotic therapy, PHL- Admin. Letter #2 approved phlebotomy, HU-hydroxyurea, interferon, busulfan, anagrelide; NO 12/28/15 2ndary AML, MDS, prior or planned stem cell transplant, Initial IRB Approval = splenectomy 10.13.2014 (site activated by sponsor 4/28/15 ) Expires July 30, 2016 EVA-17261-00 Qualitative Interviews in Patients with Hepatocellular Non-interventional protocol. HN-4808 exp. Carcinoma (HCC): Relevant Items from the Patient-Reported Outcomes Version of the Common Terminology Criteria for One-to-one interview (90 minutes) between study Pts = ______Adverse Events (PRO-CTCAE) sponsor and consenting subjects. Q of L will include: Eligibility: Confirmation (histologic or clinical) confirmation of FACT-Hep NOTE: Open only at main HCC; Child-Pugh A or B; ECOG PS 0-1; may be uninfected or PRO-CTCAE campus (EMCP) HBV, HCV positive. NO fibrolamellar or mixed cholangio- EQ-5D carcinoma, active co-infection with Hep B & C; hepatitis other IRB Approval expires 2/24/17 than B or C; NO brain mets (known or suspected); NO prior liver transplant; NO known anti-PD-1/PD-L-1 treatment;

Supportive Care – Continued STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY Varenicline (Chantix) Study Extended Duration Varenicline for Smoking among Cancer Chantix/Varenicline + counseling for 24 weeks versus Sponsor: Univ. of Penn Patients: A Clinical Trial 12 weeks Study Contact @ AEMC: Tracy Kane (215) 456-4709 Eligible subjects will be males and females: 1. > 18 years old; self-report smoking, on average, > 5 cigarettes (menthol and non-menthol)/ week, for the last 6 months. 2. Diagnosed w/cancer (all sites) within the past 5 years; if diagnosed >5 years ago, diagnosis must be currently active. 3. Karnofsky Score of > 60 or ECOG PS < 2 within 6 months of enrollment. 4. Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation. 5. Residing in the geographic area for at least 12 months. 6. Women of childbearing potential (based on medical history and physical exam) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are taking study medication and for at least one month after the medication period ends. 7. Able to communicate fluently in English. 8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form Wiser (lymphedema) Study The Women in Steady Exercise Research (WISER) study info The intervention focuses on the effects of Sponsor: NCI/Penn exercise and weight loss. Study Contact @ Penn: Eligibility Criteria: One year out breast cancer survivors with Renata Alford (215) 827-9549 lymphedema

Multiple Cancer Diagnoses (Breast, Ovarian, & Colon) CPTAC Clinical Proteomics Tumor Analysis Consortium Pre-op blood and surgical tissue (see SOP)

Study Contacts: Eligibility: Breast – page 8 of SOP Colon – page 21 of SOP Ovarian – page 26 of SOP

Trials Pending Activation – none pending 3.21.16

STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY

DATE: October 24, 2014

SUBJECT: ECOG-ACRIN PCO Move

The ECOG Pathology Coordinating Office – Reference Laboratory (PCO) currently located at Northwestern University in Chicago is moving to the new ECOG- ACRIN Central Biorepository and Pathology Facility (EA CBPF) at The University of Texas M.D. Anderson Cancer Center in Houston effective November 3, 2014. Please DO NOT send any specimens to the new location prior to the effective date.

Effective November 3, 2014, all samples originally intended for shipment to the PCO must be shipped to the new Central Biorepository and Pathology Facility (EA CBPF) at the address below:

ECOG-ACRIN Central Biorepository and Pathology Facility MD Anderson Cancer Center Department of Pathology, Unit 085 Tissue Qualification Laboratory for ECOG-ACRIN, Room G1.3586 1515 Holcombe Blvd Houston, TX 77030 Phone: Toll Free 1-844-744-2420 (713-745-4440 Local or International Sites) Fax: 713-563-6506 Email: [email protected]

In order to assist sites, the Sample Tracking System shipment manifests will be updated with this information. Protocols will be updated on a rolling basis, but please note that regardless of the protocol language all protocol shipments to the PCO must be sent instead to the EA CBPF at M.D. Anderson starting November 3rd. Kit ordering and pre-paid FedEx (as applicable, per protocol) are unaffected by the move. Shipments to any other banks or investigating laboratories are unaffected by the PCO-EA CBPF move. While archived materials are in transit to the EA CBPF, shipping of materials to investigators will be processed on a case-by-case basis. Please contact the ECOG-ACRIN translational science team at [email protected] or (617) 632-3610 with any questions.