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

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Paclitaxel

• Registration Number: NCT01024062
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-02
• Disposition First Submitted: 2010-02-02
• Disposition First Submitted QC: 2010-02-02
• Disposition First Posted: 2010-02-04
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
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	Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety: incidence and severity of adverse events, laboratory test abnormalities	Each 49 day course of treatment until withdrawal or unacceptable toxicity

Secondary Outcome Measures

Name	Time	Method
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