Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study
6 other identifiers
interventional
156
1 country
125
Brief Summary
This partially randomized phase I/II trial studies the side effects and best dose of sunitinib malate and to see how well it works when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cisplatin or carboplatin and etoposide are more effective when given with or without sunitinib malate in treating small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2007
Longer than P75 for phase_1
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2007
CompletedFirst Submitted
Initial submission to the registry
March 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2013
CompletedResults Posted
Study results publicly available
April 14, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2015
CompletedApril 4, 2023
March 1, 2023
6.3 years
March 27, 2007
March 24, 2015
March 31, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)
The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by \> 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue \< grade 3 with thyroid replacement therapy).
21 days
Progression-free Survival (Phase II)
Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.
Up to 3 years
Secondary Outcomes (2)
Overall Survival
Up to 3 years
Number of Participants With Overall Tumor Response
Up to 3 years
Other Outcomes (2)
Change in Plasma Levels of VEGF Prior to, During Single-agent, and Following Treatment With Sunitinib Malate
Baseline to within 7 days of sunitinib/placebo therapy discontinuation
Change in Plasma Levels of PDGF
Baseline to within 7 days of sunitinib/placebo therapy discontinuation
Study Arms (2)
Arm I (Combination Chemotherapy + Sunitinib Maintenance)
EXPERIMENTALParticipants will receive the following combination chemotherapy for 4-6 cycles (21 days): Cisplatin 80 mg/m\^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5\* by IV Etoposide 100 mg/m\^2 by IV over 1 hour on days 1, 2, and 3 every cycle Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
Arm II (Combination Chemotherapy + Placebo Maintenance)
ACTIVE COMPARATORParticipants will receive the following combination chemotherapy for 4-6 cycles (21 days): Cisplatin 80 mg/m\^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5\* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
Interventions
Given IV
Given IV
Given IV
Correlative studies
Given PO
Eligibility Criteria
You may qualify if:
- All patients must have histologically or cytologically documented small cell lung cancer
- Eligible disease stages: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastatic, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy
- All patients must have measurable disease:
- Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan
- Lesions that are considered non-measurable, which would make the patient not eligible, include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- No prior chemotherapy for small cell lung cancer (SCLC)
- Radiation therapy must have been completed at least one week before initiation of protocol therapy
- Common Toxicity Criteria (CTC) performance status:
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (125)
Arroyo Grande Community
Arroyo Grande, California, 93420, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
El Camino Hospital
Mountain View, California, 94040, United States
Highland General Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists-Gainesville Cancer Center
Gainesville, Florida, 32605, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, 60525, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Holy Family Medical Center
Monmouth, Illinois, 61462, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
OSF Saint Anthony Medical Center
Rockford, Illinois, 61108, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, 61362, United States
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930, United States
Lakeland Hospital Niles
Niles, Michigan, 49120, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, 68510, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, 69101, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, 03106, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, 10035, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Miriam Hospital
Providence, Rhode Island, 02906, United States
Beaufort Memorial Hospital
Beaufort, South Carolina, 29902, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Related Publications (2)
Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
PMID: 36184621DERIVEDReady NE, Pang HH, Gu L, Otterson GA, Thomas SP, Miller AA, Baggstrom M, Masters GA, Graziano SL, Crawford J, Bogart J, Vokes EE. Chemotherapy With or Without Maintenance Sunitinib for Untreated Extensive-Stage Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase II Study-CALGB 30504 (Alliance). J Clin Oncol. 2015 May 20;33(15):1660-5. doi: 10.1200/JCO.2014.57.3105. Epub 2015 Mar 2.
PMID: 25732163DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Neal Ready
- Organization
- Duke University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Neal E Ready
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2007
First Posted
March 28, 2007
Study Start
March 15, 2007
Primary Completion
June 30, 2013
Study Completion
August 20, 2015
Last Updated
April 4, 2023
Results First Posted
April 14, 2015
Record last verified: 2023-03