S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: carboplatin; Drug: cisplatin; Drug: gemcitabine; Drug: docetaxel; Drug: paclitaxel; Drug: vinorelbine

• Registration Number: NCT00003587
• Lead Sponsor: SWOG Cancer Research Network

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: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer

Detailed Description

OBJECTIVES: I. Assess the survival and failure free survival of patients with advanced primary non-small cell lung cancer treated with carboplatin and gemcitabine followed by paclitaxel OR cisplatin and vinorelbine followed by docetaxel. II. Evaluate the response (confirmed plus unconfirmed) and toxicities associated with these two regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of carboplatin and gemcitabine, patients receive paclitaxel IV over 3 hours on day 1 every 21 days for 3 courses. Arm II: Patients receive cisplatin IV over 30-60 minutes on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of cisplatin and vinorelbine, patients receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses. Patients receive no further treatment until evidence of disease progression. Patients are followed every 2 months for the first year, every 6 months for years 2 and 3, and annually thereafter.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

Study Timeline

• Study Start: 1998-10
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-01
• Study First Submitted QC: 2004-09-10
• Study First Posted: 2004-09-13
• Study Completion: 2007-01
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-05
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carboplatin/gemcitabine/paclitaxel	gemcitabine	IV carboplatin AUC=5.5 day 1 every 21 days X 3 IV gemcitabine 1,000 mg/m\^2/day, days 1 and 8 every 21 days X3 IV paclitaxel 225 mg/m\^2/day, day 1 every 21 days X 3
carboplatin/gemcitabine/paclitaxel	carboplatin	IV carboplatin AUC=5.5 day 1 every 21 days X 3 IV gemcitabine 1,000 mg/m\^2/day, days 1 and 8 every 21 days X3 IV paclitaxel 225 mg/m\^2/day, day 1 every 21 days X 3
carboplatin/gemcitabine/paclitaxel	paclitaxel	IV carboplatin AUC=5.5 day 1 every 21 days X 3 IV gemcitabine 1,000 mg/m\^2/day, days 1 and 8 every 21 days X3 IV paclitaxel 225 mg/m\^2/day, day 1 every 21 days X 3
cisplatin/vinorelbine/docetaxel	docetaxel	IV cisplatin 100 mg/m\^2 day 1 every 21 days X 3 IV vinorelbine 25 mg/m\^2/day, days 1 and 8 every 21 days X 3 IV docetaxel 75 mg/m\^2 day 1 every 21 days X 3
cisplatin/vinorelbine/docetaxel	cisplatin	IV cisplatin 100 mg/m\^2 day 1 every 21 days X 3 IV vinorelbine 25 mg/m\^2/day, days 1 and 8 every 21 days X 3 IV docetaxel 75 mg/m\^2 day 1 every 21 days X 3
cisplatin/vinorelbine/docetaxel	vinorelbine	IV cisplatin 100 mg/m\^2 day 1 every 21 days X 3 IV vinorelbine 25 mg/m\^2/day, days 1 and 8 every 21 days X 3 IV docetaxel 75 mg/m\^2 day 1 every 21 days X 3

Trial Locations

Locations (84)

MBCCOP - University of South Alabama; 🇺🇸 Mobile, Alabama, United States

CCOP - Greater Phoenix; 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Hayden); 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson; 🇺🇸 Tucson, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan); 🇺🇸 Little Rock, Arkansas, United States

Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

Veterans Affairs Medical Center - Long Beach; 🇺🇸 Long Beach, California, United States

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

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