Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery

NCT ID: NCT00004887

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31

Brief Summary

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.

Detailed Description

OBJECTIVES:

• Compare the one and two year survival of patients with inoperable advanced non-small cell lung cancer treated with paclitaxel and cisplatin versus standard platinum therapy.
• Compare the toxic effects of these two regimens in this patient population.
• Compare the performance status, tumor response, and quality of life in these patients after these treatment regimens.

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:

• Arm I: Patients receive paclitaxel IV over 3 hours, followed by carboplatin IV over 30 minutes on day 1.
• Arm II: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1 OR mitomycin IV, vinblastine IV, and cisplatin IV over 4 hours on day 1.

Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

mitomycin C

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

vinblastine sulfate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Measurable or evaluable disease

• No bony lesions as only site of measurable disease
• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2 (ECOG 3 allowed in some cases)

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST or ALT no greater than 3 times ULN (no greater than 5 times ULN for liver metastases)

Renal:

• Creatinine normal OR
• Creatinine clearance at least 60 mL/min

Other:

• Not pregnant
• Fertile patients must use effective contraception during and for 3 months after study
• No active infection
• No other serious systemic disorder that would preclude compliance
• No second malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
• No peripheral neuropathy, significant neurological disorders (e.g., seizures), or psychiatric disorders

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• Prior radiotherapy allowed if measurable disease outside of irradiated field

Surgery:

• See Disease Characteristics

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Christie NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

Nick Thatcher, PhD, FRCP

Role: STUDY_CHAIR

The Christie NHS Foundation Trust

Locations

Christie Hospital N.H.S. Trust

Manchester, England, United Kingdom

Countries

United Kingdom

Other Identifiers

CHNT-PC/MIC

Identifier Type: -

Identifier Source: secondary_id

EU-99046

Identifier Type: -

Identifier Source: secondary_id

CDR0000067562

Identifier Type: -

Identifier Source: org_study_id