Paclitaxel & Carboplatin Chemotherapy Compared With Standard Chemotherapy

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00004887
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	January 1999

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms