Carboplatin Plus Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
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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.
PURPOSE: Phase I/II trial to study the effectiveness of combining carboplatin and vinorelbine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: vinorelbine ditartrate |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Carboplatin and Navelbine for Advanced Non-Small Cell Lung Cancer |
| Study Start Date: | August 1999 |
| Study Completion Date: | March 2002 |
| Primary Completion Date: | March 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the feasibility of chemotherapy with carboplatin and vinorelbine in patients with stage IIIB or IV non-small cell lung cancer. II. Determine the maximum tolerated dose and dose limiting toxicities of this regimen in these patients. III. Determine the response rate and survival of these patients after this treatment.
OUTLINE: This is a dose escalation study of vinorelbine. Patients receive carboplatin IV over 30 minutes followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity. Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study over 6-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage IIIB or IV non-small cell lung cancer
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Other: No significant active infection No other severe medical illness No prior significant symptomatic peripheral neuropathy (grade 2 or worse) No concurrent neuropathy Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen No prior vinorelbine Endocrine therapy: Not specified Radiotherapy: Recovered from any prior radiotherapy No prior radiotherapy to more than 10% of bone marrow Surgery: At least 2 weeks since prior major surgery and recovered Other: At least 30 days since prior experimental therapy
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Gregory A. Masters, MD | Robert H. Lurie Cancer Center |
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004096 History of Changes |
| Other Study ID Numbers: | NU 99L2, NU-99L2, NCI-G99-1589 |
| Study First Received: | December 10, 1999 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
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 Vinorelbine |
Vinblastine Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013