Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Phase 3

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00003589
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.

Detailed Description

OBJECTIVES: I. Compare the overall survival between paclitaxel/cisplatin (arm I), gemcitabine/cisplatin (arm II), and paclitaxel/gemcitabine (arm III) in patients with advanced non-small cell lung cancer. II. Determine the response rate, duration of response, progression-free survival, toxicity, and quality of life of these patients randomized in these three treatment arms.

OUTLINE: This is randomized, multicenter study. Patients are stratified according to performance status (0-1 vs 2) and stage of disease (locally advanced vs metastatic). Patients are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin IV on day 1 every 3 weeks (arm I), gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin IV on day 1 every 3 weeks (arm II), or paclitaxel IV over 3 hours on day 1 followed by gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks (arm III). Patients receive at least 2 courses of treatment. In the absence of unacceptable toxicity and disease progression, patients may receive up to 6 courses of treatment. Quality of life is assessed before, during, and at the end of treatment, then every 6 weeks until disease progression, and then every 3 months until death. Patients are followed every 6 weeks until disease progression, then every 3 months until death.

PROJECTED ACCRUAL: A total of 450 patients (150 patients per arm) will be accrued into this study over 36 months.

Study Timeline

• Study Start: 1998-08
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-07
• Study First Submitted QC: 2004-07-12
• Study First Posted: 2004-07-13
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-05
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (33)

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerp, Belgium

University Hospital Bulovka; 🇨🇿 Krhanice, Czech Republic

National Cancer Institute of Egypt; 🇪🇬 Cairo, Egypt

CHRU de Nancy - Hopitaux de Brabois; 🇫🇷 Vandoeuvre-Les-Nancy, France

Thoraxklinik Rohrbach; 🇩🇪 Heidelberg, Germany

Hippokration General Hospital of Athens; 🇬🇷 Athens, Greece

Ospedale degli Infermi; 🇮🇹 Biella, Italy

Leyenburg Ziekenhuis; 🇳🇱 's-Gravenhage (Den Haag, The Hague), Netherlands

Groot Ziekengasthuis 's-Hertogenbosch; 🇳🇱 's-Hertogenbosch, Netherlands

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

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