SWOG clinical trial number
S0802

A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept; NSC-724770) in Patients with Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)

Closed
Phase
Accrual
100%
Published
Abbreviated Title
AVE0005 in E-SCLC, Randomized Ph II
Activated
05/15/2009
Closed
03/01/2012
Participants
NCORP, Members, Medical Oncologists, Affiliates

Research committees

Lung Cancer

Treatment

Topotecan AVE0005

Eligibility Criteria Expand/Collapse

Histologically or cytologically confirmed diagnosis of SCLC with progression or recurrence after receiving exactly one standard first-line platinum-containing regimen. Must have extensive disease at time of protocol entry. Measurable or non-measurable disease. Brain mets eligible only if has been treated and stable for at least 3 months. No leptomeningeal involvement or brain stem mets. At least 21 days since prior RT. At least 28 days since surgery. No prior bevacizumab or other anti-angiogenic tx. Zubrod PS 0-1. At least 18 years of age. No active infection or bleeding. No uncontrolled hypertension. No history of recent arterial embolic events or congestive heart failure. No significant history of bleeding diathesis including hemoptysis or underlying coagulopathy. No prior history of encephalitis or encephalopathy. No diverticulitis, GI bleeding, or peptic ulcer within prior 3 months. Must be willing to provide smoking history. No known AIDS or HIV-1. Within 28 days prior to reg: assess measurable disease; CT or MRI of brain; ANC>/=1,500/mcl; hemoglobin >/=10 g/dL; platelets >/=100,000/mcl; serum creatinine </=1.5 x IULN or measured or calculated creatinine clearance >/= 60 mL/min; UPC ratio < 1 or 24-hour urine < 500. Within 42 days prior to reg: assess non-measurable disease.

Publication Information Expand/Collapse

2016

Disease control rate at 8 weeks predicts subsequent survival in platinum-treated extensive stage small cell lung cancer (ES-SCLC): a patient level analysis of SWOG trials

P Lara;J Moon;M Redman;T Semrad;K Kelly;JW Allen;B Gitlitz;PC Mack;D Gandara Clinical Lung Cancer, Mar;17(2):113-118

PMid: PMID26498504 | PMC number: PMC4789142

2015

Relevance of platinum sensitivity status in relapsed/refractory extensive stage small cell lung cancer (ES-SCLC) in the modern era: a patient level analysis of SWOG trials

P Lara;J Moon;M Redman;T Semrad;K Kelly;JW Allen;B Gitlitz;PC Mack;D Gandara Journal of Thoracic Oncology 10(1):110-115

PMid: PMID25490004 | PMC number: PMC4320001

Reply to "diminishing role of platinum-sensitivity status in patients with small cell lung cancer"

P Lara;D Gandara;M Redman Journal of Thoracic Oncology 2015 May;10(5):e36

PMid: PMID25898968 | PMC number: letter to editor not within scope of Public Access Policy

2014

SWOG S0802: a randomized phase II trial of weekly topotecan with and without afilbercept in patients with platinum-treated extensive state small cell lung cancer

J Allen;J Moon;M Redman;S Gadgeel;K Kelly;P Mack;H Saba;MK Mohamed;M Jahanzeb;D Gandara;JW Allen Journal of Clinical Oncology 32(23):2463-2470;

PMid: PMID25002722 | PMC number: PMC4121504

2013

Relevance of platinum (plat) sensitivity status in previously treated extensive stage small cell lung cancer (ES-SCLC) in the modern era: a patient level analysis of SWOG trials

P Lara, Jr;J Moon;M Redman;K Kelly;J Allen;B Gitlitz;PC Mack;D Gandara Journal of Clinical Oncology 31(suppl; abstr 7511); ASCO Annual Meeting (May 31-June 4, 2013, Chicago, IL), poster discussion;

Disease control rate at 8 weeks predicts subsequent survival in platinum-treated extensive stage small cell lung cancer (ES-SCLC): a patients level analysis of SWOG trials

P Lara;J Moon;M Reddman;K Kelly;J Allen;B Gitlitz;PC Mack;D Gandara Journal of Thoracic Oncology 8(suppl. 2): abstr. MO13.01; the 15th World Conference on Lung Cancer, October 2013, Sydney, Australia

2012

SWOG 0802: A Randomized Phase II Trial of Weekly Topotecan With and Without AVE0005 (Aflibercept) in Patients with Platinum-treated Extensive Stage Small Cell Lung Cancer (E-SCLC)

J Allen;J Moon;S Gadgeel;K Kelly;PC Mack;H Saba;MK Mohamed;D Gandara J Clin Oncol 30 (suppl; abstr 7005);American Society of Clinical Oncology 2012 Annual Mtg (June 1-5, 2012, Chicago, IL), oral presentation;

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