Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects

Official Title
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Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel<br> | Drug: Paclitaxel<br>* Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent<br>* Other names: BMS-181339;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With SAEs | Number of Participants with SAEs | From the first infusion to the completion of study. Approximately up to 28 months | 
| Number of Participants With Adverse Events Leading to Discontinuation | Number of Participants with Adverse Events Leading to Discontinuation | From the first infusion to the completion of study. Approximately up to 28 months | 
| Number of Participants With Adverse Events | Number of Participants with Adverse Events | From the first infusion to the completion of study. Approximately up to 28 months | 
| Number of Participants With Laboratory Abnormalities | Number of Participants with Laboratory Abnormalities | From the first infusion to the completion of study. Approximately up to 28 months | 
| Number of Participants With Drug Related Laboratory Abnormalities | Number of Participants with Drug Related Laboratory Abnormalities | From the first infusion to the completion of study. Approximately up to 28 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Best Overall Response Per RECIST Criteria | Best overall response is represented by the number participants who have had complete response, partial response and have stable disease. | From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months | 
| Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer | Best overall response is represented by the number participants who have had complete response, partial response and not completed. | From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months | 
| Duration of Overall Response as Per RECIST Criteria | DOR is defined as the median time from the first date of Partial Response to the first date of Progressive Disease. Participants were evaluated for DOR in a separate study (NCT00971867). | From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months | 
| Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer | Best overall response is represented by the number participants who have had complete response, partial response and not completed. | From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months |