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Sponsored by: |
Christie Hospital NHS Foundation Trust |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004887 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel and carboplatin is more effective than standard chemotherapy for advanced non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin chemotherapy with that of standard chemotherapy in treating patients who have stage III or stage IV non-small cell lung cancer that cannot be removed during surgery.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: ifosfamide Drug: mitomycin C Drug: paclitaxel Drug: vinblastine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Comparative Study of Paclitaxel With Carboplatin Versus Mitomycin, Ifosfamide, Cisplatin (MIC) Chemotherapy in Inoperable Advanced Stage Non-Small Cell Lung Cancer |
Study Start Date: | January 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, stage of disease (IIIA vs IIIB vs IV), or performance status (ECOG O vs 1 vs 2 vs 3).
Patients are randomized to one of two treatment arms:
Quality of life is assessed before each treatment course.
Patients are followed for survival.
PROJECTED ACCRUAL: Approximately 300 patients (150 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed inoperable advanced non-small cell lung cancer
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
Christie Hospital N.H.S. Trust | |
Manchester, England, United Kingdom, M20 4BX |
Study Chair: | Nick Thatcher, PhD, FRCP | Christie Hospital NHS Foundation Trust |
Study ID Numbers: | CDR0000067562, CHNT-PC/MIC, EU-99046 |
Study First Received: | March 7, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004887 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Vinblastine Antimitotic Agents Carboplatin Mitomycins Carcinoma Anti-Bacterial Agents Ifosfamide Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Mechlorethamine Lung Diseases Tubulin Modulators Mitomycin Non-small Cell Lung Cancer Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Isophosphamide mustard |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vinblastine Antibiotics, Antineoplastic Mitomycins Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Mitomycin Alkylating Agents Nucleic Acid Synthesis Inhibitors |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms Ifosfamide Radiation-Sensitizing Agents Paclitaxel Lung Diseases Tubulin Modulators Antineoplastic Agents, Alkylating |