Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer

Phase 2

Completed

• Conditions: Esophageal Cancer
• Interventions: Drug: Paclitaxel

• Registration Number: NCT00971841
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced or recurrent esophageal cancer who have completed the previous Phase 2 study (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating investigator(s). To evaluate the severity of observed adverse reactions in treated subjects for assessment of long-term safety.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-05-24
• Results First Submitted QC: 2013-05-24
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-18
• Results First Posted: 2013-07-19
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel	Paclitaxel	One hour intravenous infusion on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consists of 49 days. Day 1 dose same level as last dose of original Study CA139-540 (100mg/m2, 80 mg/m2, or 60 mg/m2). Treatment to continue until disease progression or unacceptable toxicity apparent.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs) Per Participant	Weekly Day 1 to 4 years	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Complete Response to Tumor	Every 7 weeks Day 1 to 4 years	Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552).