Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: paclitaxel

• Registration Number: NCT00005646
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have extensive-stage small cell lung cancer.

Detailed Description

OBJECTIVES: I. Determine the complete and overall response rate to paclitaxel in patients with previously untreated extensive stage small cell lung cancer. II. Determine the overall and progression free survival of these patients in response to this treatment regimen. III. Determine the toxicity of this treatment regimen in this patient population.

OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours weekly for 6 consecutive weeks. Treatment continues every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, then every 3 months for 2 years, and then annually for 2 years.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2000-05-02
• Study First Submitted QC: 2003-12-16
• Study First Posted: 2003-12-17
• Primary Completion: 2004-01
• Study Completion: 2008-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel	paclitaxel	Patients receive paclitaxel for up to 4 cycles. One cycle = weekly drug for 6 weeks and 2 weeks rest

Primary Outcome Measures

Name	Time	Method
Response Rate	1 year post treatment

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	12 months post treatment
Overall survival	12 months post treatment
Overall response	12 months
Toxicity	1 year post treatment

Trial Locations

Locations (5)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

State University of New York - Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Ellis Fischel Cancer Center - Columbia; 🇺🇸 Columbia, Missouri, United States

Lineberger Comprehensive Cancer Center, UNC; 🇺🇸 Chapel Hill, North Carolina, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States