Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Extensive Stage Small Cell Lung Cancer
In brief
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
Key facts
- Study ID
- NCT00057837
- Run by
- Eastern Cooperative Oncology Group
- People needed
- 140
- Starts
- 2004-07-14
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2023-07-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated within 2 weeks prior to randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Disease-free for >=5 years if had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Adequate hematologic, hepatic and renal function determined by the following tests, within 4 weeks prior to randomization: white blood cell (WBC) >=4000/mm3 and platelets >=100,000/mm3; bilirubin <= upper limit of normal; serum glutamic pyruvate transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic transaminase (SGOT) or aspartate transaminase( AST) <=2.5 x upper limit of normal if no demonstrable liver metastases or <=5 times upper limit of normal in the presence of liver metastases; Calculated creatinine clearance >=30 using the formulas in the protocol
- Age 18 and older
- Strongly advised to use an accepted and effective method of contraception
- Those with central nervous system (CNS) metastases were eligible if the metastases were treated without advancing symptoms prior to the initiation of chemotherapy
- Those receiving erythropoietin could continue to receive it
You may not qualify if…
- Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central nervous system (CNS) metastases
- Prior chemotherapy for this disease
- Pregnant or lactating
Where it is running
- CCOP - Christiana Care Health Services — Newark, Delaware, United States
- Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
- University of Miami Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States
- Medical Center of Central Georgia — Macon, Georgia, United States
- Rush-Copley Cancer Care Center — Aurora, Illinois, United States
- Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
- Hematology & Oncology Care — Moline, Illinois, United States
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus — Moline, Illinois, United States
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields — Olympia Fields, Illinois, United States
- Swedish-American Regional Cancer Center — Rockford, Illinois, United States
- Carle Cancer Center at Carle Foundation Hospital — Urbana, Illinois, United States
- CCOP - Carle Cancer Center — Urbana, Illinois, United States
- Elkhart General Hospital — Elkhart, Indiana, United States
- Howard Community Hospital — Kokomo, Indiana, United States
- Center for Cancer Therapy at LaPorte Hospital and Health Services — La Porte, Indiana, United States
- Clarian Arnett Cancer Care — Lafayette, Indiana, United States
- Saint Anthony Memorial Health Centers — Michigan City, Indiana, United States
- CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
- Memorial Hospital of South Bend — South Bend, Indiana, United States
- Saint Joseph Regional Medical Center — South Bend, Indiana, United States
- Study site — Bettendorf, Iowa, United States
- Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
- Mercy Medical Center - Sioux City — Sioux City, Iowa, United States
- St. Luke's Regional Medical Center — Sioux City, Iowa, United States
- Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States
Full record on ClinicalTrials.gov
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