NCT00003587

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

Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

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

Timeline

• Start date: 1998-10-01
• Primary completion: 2001-01-01
• Completion: 2007-01-01
• First posted: 2004-09-13
• Last updated: 2012-10-08

Locations

84 sites across 1 country: United States