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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) North Central Cancer Treatment Group Eastern Cooperative Oncology Group Southwest Oncology Group |
| Information provided by: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00003299 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: etoposide Drug: paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer |
| Enrollment: | 587 |
| Study Start Date: | April 1998 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Cisplatin + Etoposide | Drug: cisplatin Drug: etoposide |
| Experimental: Cisplatin + Etoposide + Paclitaxel | Drug: cisplatin Drug: etoposide Drug: paclitaxel |
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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
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
Contacts and Locations| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CentraCare Clinic | |
| Saint Cloud, Minnesota, United States, 56303 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| United States, North Dakota | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501 | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Altru Health Systems | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Ohio | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57105-1080 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Study Chair: | Harvey B. Niell, MD | Veterans Affairs Medical Center - Memphis |
| Study Chair: | Randolph S. Marks, MD | Mayo Clinic |
| Study Chair: | Alan B. Sandler, MD | Vanderbilt-Ingram Cancer Center |
| Study Chair: | Karen Kelly, MD | University of Colorado, Denver |
More Information
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00003299 History of Changes |
| Other Study ID Numbers: | CDR0000066238, U10CA031946, CLB-9732, E-C9732, NCCTG-C9732, SWOG-C9732 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
extensive stage small cell lung cancer |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Etoposide phosphate Cisplatin |
Etoposide Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
