Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Recruitment status was Active, not recruiting
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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 three courses of combination chemotherapy are more effective than six courses of combination chemotherapy for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of three courses of combination chemotherapy with that of six courses of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: mitomycin C Drug: vinblastine sulfate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Study of MVP 3 Versus 6 Cycles in Advanced Non-Small Cell Lung Cancer |
| Study Start Date: | May 1998 |
OBJECTIVES: I. Compare the duration of symptom control, time to disease progression, survival, and quality of life in patients with stage IIIB or IV non-small cell lung cancer treated with 3 versus 6 courses of mitomycin, vinblastine, and cisplatin.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by stage of disease (stage IIIB vs IV). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive cisplatin IV over 4 hours, mitomycin IV, and vinblastine IV on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Mitomycin is not administered during course 3. Arm II: Patients receive chemotherapy as in arm I. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Mitomycin is not administered during courses 3 and 5. Quality of life is assessed after completion of 3 courses of chemotherapy for patients in arm I and after completion of 4, 5, and 6 courses for those in arm II. Patients may receive radiotherapy beginning after completion of chemotherapy.
PROJECTED ACCRUAL: A total of 310 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven stage IIIB or IV non-small cell lung cancer that is not eligible for surgery or radical radiotherapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod-WHO 0-2 Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 10 g/dL WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Liver function tests no greater than 2 times normal (unless due to metastatic disease) Renal: Creatinine clearance greater than 60 mL/min EDTA clearance greater than 60 mL/min Other: No serious, uncontrolled, concurrent medical illness
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior conventional chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Contacts and Locations| United Kingdom | |
| Royal Marsden NHS Trust | |
| London, England, United Kingdom, SW3 6JJ | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Study Chair: | Ian E. Smith, MD | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004209 History of Changes |
| Other Study ID Numbers: | CDR0000067457, ICRF-95.240, EU-99017 |
| Study First Received: | January 21, 2000 |
| Last Updated: | November 2, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Mitomycins Mitomycin Cisplatin Vinblastine |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on May 19, 2013