S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT00828139
Last Updated: 2017-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
189 participants
INTERVENTIONAL
2009-05-31
2012-09-30
Brief Summary
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Detailed Description
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I. Evaluate the efficacy of topotecan hydrochloride with vs without aflibercept (ziv-aflibercept), in terms of progression-free survival at 3 months, in patients with extensive stage small cell lung cancer previously treated with platinum-based therapy.
SECONDARY OBEJCTIVES:
I. Assess the response rate (confirmed and unconfirmed, complete and partial responses) in a subset of patients with measurable disease.
II. Assess the overall survival of these patients. III. Evaluate the frequency and severity of toxicities of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior platinum-based therapy (platinum-sensitive disease vs platinum-refractory disease). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ziv-aflibercept IV over 1 hour on day 1 and topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive ziv-aflibercept IV on day 1 and topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for up to 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (ziv-aflibercept, topotecan hydrochloride)
Patients receive ziv-aflibercept IV over 1 hour on day 1 and topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive ziv-aflibercept IV on day 1 and topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept
Given IV
topotecan hydrochloride
Given IV
Arm II (topotecan hydrochloride)
Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
topotecan hydrochloride
Given IV
Interventions
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ziv-aflibercept
Given IV
topotecan hydrochloride
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressive or recurrent disease following one (and only one) standard first-line platinum-containing regimen (cisplatin or carboplatin)
* Measurable or non-measurable disease per RECIST criteria
* Disease must be outside a previously irradiated field OR a new lesion must be inside the irradiated field
* Disease must be outside a previously resected area OR a new lesion must be present
* No known brain metastasis unless the metastasis has been treated and is stable for ≥ 3 months prior to study entry
* No leptomeningeal involvement or brain stem metastasis
* Zubrod performance status 0-1
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 60 mL/min
* Urine protein: creatinine ratio \< 1 OR urine protein \< 500 mg by 24-hour urine collection
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Willing to provide smoking history
* No evidence of active infection
* No active bleeding
* No significant history of bleeding diathesis, including hemoptysis (½ teaspoon of hemoptysis within the past 3 months), or underlying coagulopathy
* No history of recent arterial embolic events, including any of the following:
* Myocardial infarction
* Cerebrovascular accident
* Transient ischemic attack
* Worsening of pre-existing angina within the past 6 months
* No uncontrolled hypertension (systolic BP \> 150 mm Hg or diastolic BP \> 100 mm Hg)
* History of hypertension allowed provided it is controlled on anti-hypertensive medications
* No history of congestive heart failure
* No history of encephalitis or encephalopathy of any cause
* No diverticulitis, gastrointestinal bleeding, or peptic ulcer within the past 3 months
* No known AIDS or HIV-1 associated complex
* No known history of immune or immunodeficiency disorders
* No unstable or pre-existing major medical conditions except for cancer-related abnormalities
* No other prior malignancy except for any of the following:
* Adequately treated basal cell or squamous cell skin cancer
* In situ cervical cancer
* Adequately treated stage I or II cancer currently in complete remission
* Any other cancer from which the patient been disease-free for 5 years
* Concurrent chronic therapeutic doses of low molecular weight heparin allowed
* At least 21 days since prior and no concurrent radiotherapy and recovered
* At least 28 days since prior and no concurrent surgery (e.g., thoracic or other major surgeries) and recovered
* No prior bevacizumab or other anti-angiogenic therapies including, but not limited to, small molecule tyrosine kinase inhibitors
* No concurrent enzyme-inducing anticonvulsant drugs
* Non-enzyme-inducing anticonvulsant drugs (e.g., Keppra) allowed
* Concurrent chronic oral anticoagulation therapy allowed provided INR is maintained in the therapeutic range (INR 2-3)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Jeffrey Allen
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Providence Hospital
Mobile, Alabama, United States
Arizona Cancer Center at UMC Orange Grove
Tucson, Arizona, United States
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States
University of Arizona Health Sciences Center
Tucson, Arizona, United States
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Highlands Oncology Group-Rogers
Rogers, Arkansas, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
City of Hope Medical Center
Duarte, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
El Camino Hospital
Mountain View, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Breast Surgeons Inc
Oakland, California, United States
Bay Area Tumor Institute CCOP
Oakland, California, United States
Larry G Strieff MD Medical Corporation
Oakland, California, United States
Tom K Lee Inc
Oakland, California, United States
Valley Care Health System - Pleasanton
Pleasanton, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
University of California at Davis Cancer Center
Sacramento, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States
San Luis Valley Regional Medical Center
Alamosa, Colorado, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
The Shaw Regional Cancer Center
Edwards, Colorado, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Montrose Memorial Hospital
Montrose, Colorado, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Piedmont Hospital
Atlanta, Georgia, United States
Atlanta Regional CCOP
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Well Star Cobb Hospital
Austell, Georgia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Dekalb Medical Center
Decatur, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
South Georgia Medical Center
Valdosta, Georgia, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Saint Anthony's Health
Alton, Illinois, United States
Cancer Care Center of Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States
Reid Hospital and Health Care Services
Richmond, Indiana, United States
Genesis Medical Center - East Campus
Davenport, Iowa, United States
Genesis Medical Center - West Campus
Davenport, Iowa, United States
Hospital District Sixth of Harper County
Anthony, Kansas, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Hays Medical Center
Hays, Kansas, United States
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Kansas City Cancer Center-West
Kansas City, Kansas, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Olathe Cancer Center
Olathe, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Stormont-Vail Regional Health Center
Topeka, Kansas, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita CCOP
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Interim LSU Public Hospital
New Orleans, Louisiana, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Holy Family Hospital
Methuen, Massachusetts, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Oakwood Hospital
Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Gulfport Memorial Hospital
Gulfport, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Singing River Hospital
Pascagoula, Mississippi, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Truman Medical Center
Kansas City, Missouri, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Saint Louis University Hospital
St Louis, Missouri, United States
Saint John's Mercy Medical Center
St Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, United States
Montana Cancer Consortium CCOP
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States
Billings Clinic
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Arnot Ogden Medical Center
Elmira, New York, United States
Adirondack Cancer Center
Glens Falls, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Columbia University Medical Center
New York, New York, United States
Highland Hospital
Rochester, New York, United States
Interlakes Foundation Inc-Rochester
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Carolinas Medical Center - Northeast
Concord, North Carolina, United States
Gaston Memorial Hospital
Gastonia, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
High Point Regional Hospital
High Point, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
Mary Rutan Hospital
Bellefontaine, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Columbus CCOP
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton CCOP
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
Genesis HealthCare System
Zanesville, Ohio, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Western Oncology Research Consortium
Portland, Oregon, United States
Adventist Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Salem Hospital
Salem, Oregon, United States
AnMed Health Hospital
Anderson, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Upstate Carolina CCOP
Spartanburg, South Carolina, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
University of Tennessee - Memphis
Memphis, Tennessee, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Methodist Hospital
Houston, Texas, United States
Saint Luke's Episcopal Hospital
Houston, Texas, United States
Veterans Administration Medical Center
Houston, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Southwest Oncology Group
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Danville Regional Medical Center
Danville, Virginia, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States
Highline Medical Center-Main Campus
Burien, Washington, United States
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States
Skagit Valley Hospital
Mount Vernon, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical PLLC
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Group Health Cooperative-Seattle
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
The Polyclinic
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, United States
Rockwood Clinic
Spokane, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Compass Oncology Vancouver
Vancouver, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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References
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Lara PN Jr, Moon J, Redman MW, Semrad TJ, Kelly K, Allen JW, Gitlitz BJ, Mack PC, Gandara DR. Relevance of platinum-sensitivity status in relapsed/refractory extensive-stage small-cell lung cancer in the modern era: a patient-level analysis of southwest oncology group trials. J Thorac Oncol. 2015 Jan;10(1):110-5. doi: 10.1097/JTO.0000000000000385.
Allen JW, Moon J, Redman M, Gadgeel SM, Kelly K, Mack PC, Saba HM, Mohamed MK, Jahanzeb M, Gandara DR. Southwest Oncology Group S0802: a randomized, phase II trial of weekly topotecan with and without ziv-aflibercept in patients with platinum-treated small-cell lung cancer. J Clin Oncol. 2014 Aug 10;32(23):2463-70. doi: 10.1200/JCO.2013.51.4109. Epub 2014 Jul 7.
Other Identifiers
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NCI-2009-01182
Identifier Type: REGISTRY
Identifier Source: secondary_id
SWOG-S0802
Identifier Type: -
Identifier Source: secondary_id
CDR0000632614
Identifier Type: -
Identifier Source: secondary_id
S0802
Identifier Type: OTHER
Identifier Source: secondary_id
S0802
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-01182
Identifier Type: -
Identifier Source: org_study_id
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