NCT00004137

S9914: Combination Chemotherapy Plus Filgrastim in Untreated Extensive-Stage Small Cell Lung Cancer

Phase II Trial of Paclitaxel, Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.

Detailed description

OBJECTIVES: I. Assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and filgrastim (G-CSF). II. Determine the side effects and toxicity of this regimen in these patients. OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study over 18 months.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	carboplatin
DRUG	paclitaxel
DRUG	topotecan hydrochloride

Timeline

• Start date: 1999-10-01
• Primary completion: 2004-03-01
• Completion: 2008-11-01
• First posted: 2004-04-12
• Last updated: 2013-02-15

Locations

85 sites across 1 country: United States