Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb0 sites60 target enrollmentDecember 2002

ConditionsNon-Small Cell Lung Cancer

InterventionsPaclitaxel

DrugsPaclitaxel

Overview

Phase: Phase 2
Intervention: Paclitaxel
Conditions: Non-Small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 60
Primary Endpoint: Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on "Response Evaluation Criteria in Solid Tumors (RECIST)" in patients with no prior chemotherapy
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent non-small cell lung cancer

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

March 2005

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

•Patients with no prior chemotherapy who meet either of the listed below:
•Patient with stage IIIB or IV disease
•Patients with recurrent disease following potentially curative surgical resection
•Patients with previous chemotherapy up to one regimen

Exclusion Criteria

•Patients with serious, uncontrolled medical illness
•Patients with previous therapy with taxanes

Arms & Interventions

Paclitaxel

Intervention: Paclitaxel

Outcomes

Primary Outcomes

Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on "Response Evaluation Criteria in Solid Tumors (RECIST)" in patients with no prior chemotherapy

Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity

Safety: incidence and severity of adverse events, laboratory test abnormalities

Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity

Secondary Outcomes

Duration of response, [measured from the time that measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively documents](Each 49 day course of treatment until withdrawal or unacceptable toxicity)