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Home > "C" Clinical Trials Conditions > Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer  Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
For Condition: extensive stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group,Eastern Cooperative Oncology Group,Southwest Oncology Group,Cancer and Leukemia Group B
Synopsis: 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 whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and etoposide alone in treating patients with extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.
Details: OBJECTIVES: I. Determine whether the addition of paclitaxel to standard chemotherapy treatment comprising etoposide and cisplatin improves the survival of patients with extensive stage small cell lung cancer. II. Compare the tumor response rate and failure-free survival of these patients treated with these regimens. III. Describe and compare the toxic effects associated with these regimens in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to performance status and gender. Patients are randomized to one of two treatment arms. Arm I: Patients receive cisplatin IV on day 1 and etoposide IV over 1 hour on days 1-3. Arm II: Patients receive paclitaxel IV over 3 hours on day 1 and cisplatin and etoposide as in arm I. Patients then receive filgrastim (G-CSF) subcutaneously on days 4-18. Treatment repeats in both arms every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 2 months for 2 years, every 4 months for 1 year, and then at least every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 670 patients (335 per arm) will be accrued for this study within 16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically documented extensive stage small cell carcinoma of the bronchus - Measurable or evaluable disease; No pleural effusions, bone scan abnormalities, or bone marrow biopsies as only evidence of disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for small cell lung cancer; No other concurrent chemotherapy - Endocrine therapy: No chronic steroid therapy (except steroids for adrenal failure or hormones for non-disease related conditions) - Radiotherapy: No prior pelvic or mediastinal radiotherapy - Surgery: Not specified - Other: No concurrent anticonvulsants --Patient Characteristics-- - Age: 18 and over - Performance status: CALGB 0-1 - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL; SGOT less than 2 times normal - Renal: Serum creatinine no greater than 1.5 mg/dL - Cardiovascular: No cardiac disease - Pulmonary: No interstitial pneumonia; No fibroid lung - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No psychiatric illness; No malabsorption disorder; No uncontrolled infection; No uncontrolled diabetes mellitus; No prior or concurrent malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardSchilsky, Study Chair, Cancer and Leukemia Group B
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Additional Information:
Study ID Numbers: CDR0000066238; CLB-9732
Study Start Date: October 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003299
Other Extensive Stage Small Cell Lung Cancer Studies:
1. Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
2. Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
3. Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
4. Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
5. Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer
Related Studies:
Other extensive stage small cell lung cancer Clinical Trials
Other Arizona Clinical Trials
Other Scottsdale Clinical Trials
Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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