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Carboplatin Plus Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carboplatin
vinorelbine ditartrate
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
May 31, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004096
Brief Title
Carboplatin Plus Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Official Title
A Phase I/II Study of Carboplatin and Navelbine for Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
March 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
vinorelbine ditartrate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Carboplatin Plus Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

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