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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045162 |
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 combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: cisplatin Drug: etoposide Drug: irinotecan hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Phase III Trial of Cisplatin (NSC-119875) and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide (NSC-141540) in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC) |
Estimated Enrollment: | 620 |
Study Start Date: | November 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of metastatic sites (single vs multiple), lactic dehydrogenase (no greater than upper limit of normal (ULN) vs greater than ULN), and weight loss in the past 6 months (5% or less vs more than 5%). Patients are randomized to 1 of 2 treatment arms.
Treatment in both arms continues for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 620 patients (310 per treatment arm) will be accrued for this study within 4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Ronald B. Natale, MD | Cedars-Sinai Medical Center |
Investigator: | David R. Gandara, MD | University of California, Davis |
Investigator: | Primo N. Lara, MD | University of California, Davis |
Investigator: | James R. Jett, MD | Mayo Clinic |
Investigator: | Jane Carleton, MD | Don Monti Comprehensive Cancer Center at North Shore University Hospital |
Study ID Numbers: | CDR0000256908, SWOG-S0124, NCCTG-S0124, CALGB-S0124 |
Study First Received: | September 6, 2002 |
Last Updated: | June 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00045162 |
Health Authority: | United States: Federal Government |
extensive stage small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Irinotecan Etoposide phosphate Camptothecin Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Etoposide Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |