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A Phase I/II Study of Carboplatin and Navelbine for Advanced Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase I/II Study of Carboplatin and Navelbine for Advanced Non-Small Cell Lung Cancer

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

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gregory A. Masters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 99L2



Start Date:

August 1999

Completion Date:

March 2002

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611