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Sponsored by: |
Commissie Voor Klinisch Toegepast Onderzoek |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003696 |
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 most effective for extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: paclitaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer |
Estimated Enrollment: | 250 |
Study Start Date: | October 1998 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to institute and performance status (0-1 vs 2-3).
Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued within 24 months for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Netherlands | |
Vrije Universiteit Medisch Centrum | |
Amsterdam, Netherlands, 1007 MB |
Study Chair: | Egbert F. Smit, MD | Free University Medical Center |
Study ID Numbers: | CDR0000066803, CKVO-9802, DUT-KWF-CKVO-9802, EU-98059 |
Study First Received: | November 1, 1999 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003696 History of Changes |
Health Authority: | United States: Federal Government |
extensive stage small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Immunologic Factors Cyclophosphamide Etoposide phosphate Anti-Bacterial Agents Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Neuroepithelioma Etoposide Alkylating Agents Antimitotic Agents Carboplatin |
Immunosuppressive Agents Doxorubicin Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Paclitaxel Lung Diseases Tubulin Modulators Antineoplastic Agents, Alkylating Adenocarcinoma Antirheumatic Agents Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Alkylating Agents |
Etoposide Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators Antimitotic Agents Carboplatin Immunosuppressive Agents Pharmacologic Actions Doxorubicin Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Paclitaxel |