SWOG clinical trial number
S0635

A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features

Closed
Phase
Accrual
95%
Abbreviated Title
Phase II OSI-774/Bevacizumab in St. IIIB and IV BAC and AdenoBAC
Activated
07/15/2007
Closed
08/15/2011
Participants
NCORP, Members, Medical Oncologists, Affiliates

Research committees

Lung Cancer

Treatment

Bevacizumab Erlotinib

Eligibility Criteria Expand/Collapse

Pts must have biopsy-proven, incompletely resected or unresectable BAC or BAC variants. No squamous ca in any histologic sample. No cytology specimens (bronchial brushings, washings, fine needle aspiration) as diagnosis of BAC/subtypes. Pts must be willing to provide prior smoking history. Pts who are never-smokers with BAC should be placed in S0636 if open at same institution. Pts must have selected St IIIB or St IV disease. Tumors may be multi focal or diffuse (see Sec. 5.3). Pts must have measurable and/or non-measurable disease documented by chest CT. Measurable disease must be assessed w/i 28days. Pleural effusions, ascites and lab parameters are not acceptable as only evidence of disease. Non-measurable disease must be assessed w/i 42 days. Pts must have no symptomatic brain mets. Pts may have rec�d prior RT completed at least 28 days prior to registration or palliative RT completed at lease 14 days prior to registration. Measurable or non-measurable disease must be present outside the previous radiation field or a new lesion inside the port must be present. Prior sx completed at least 28 days prior to registration is allowed. Pts must not have had a fine needle or core bx w/i 7 days. Pts may have rec�d systemic chemo (d/c w/i 28 days) or bio therapy. No prior tx with ZD1839, OSI-774, bevacizumab, or other EGFR or VEGF targeted tx. Pts must not have had hemoptysis >/= � tsp w/i 28 days. Pts must not have had clinical history of pulmonary/upper resp hemorrhage >/= Grade 2 w/i 6 months of Grade 1 w/i 28 days; no history of thrombosis or hemorrhage. Pts must have adequate hepatic function: bili </= 1 x IULN and SGOT or SGPT </= 2.5 x IULN. If liver mets are present, SGOT/SGPT </= 5x IULN. Adequate renal function: serum creat </= 1.5 x IULN or calc or measured creat clearance >/= 50 using formula in Sec 5.13. For UPC ratio >0.5, 24-hour urine protein must be obtained w/i 28 days and the level <1000 (use formula in Sec.5.14). ANC >/= 1,5000, platelet >/= 100,000. Controlled hypertension allowed. Pts must have PS 0-2, 18 years or older. Pts strongly encouraged to submit specimens as outlined in Sec. 15.0. Pts must not be receiving or planning to receive sx or other non-protocol tx (including chemo, hormone, bio, or RT) directed at the BAC. Pts must not have serious non-healing wound, ulcer, or bone fx. No other prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical, Stage I or II ca in complete remission; disease-free from any ca for 5 years. No pregnant or nursing women.




Publication Information Expand/Collapse

2018

Paired Phase II Studies of Erlotinib/Bevacizumab in Advanced Bronchioloalveolar Carcinoma or in Never-Smokers with Advanced Non-Small-Cell Lung Cancer (NSCLC): SWOG S0635 and S0636

HL West;J Moon;A Wozniak;PC Mack;F Hirsch;MJ Bury;MS Kwong;DD Nguyen;DF Moore;J Miao;M Redman;K Kelly;DR Gandara Clinical Lung Cancer Jan;19(1):84-92;

PMid: PMID28801183 | PMC number: PMC5748264

2012

SWOG S0635 and S0636: Phase II Trials of Erlotinib (OSI-774)(E) and Bevacizumab (B) in Advanced (Adv) Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features (adenoBAC), or in Never-Smokers with Primary Adv NSCLC Adenocarcinoma (adenoCa)

H West;J Moon;F Hirsch;PC Mack;A Wozniak;D Lau;L Fehrenbacher;M Bury;M Redman;D Gandara J Clin Oncol 30 (suppl; abstr 7517); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), poster discussion;