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Completed

NCT Number: NCT00971867

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

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

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Kashiwa-shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent

Other names: Taxol, BMS-181339

Primary outcomes

  1. Number of Participants With SAEs

    Time frame: From the first infusion to the completion of study. Approximately up to 28 months

    Number of Participants with SAEs

  2. Number of Participants With Adverse Events Leading to Discontinuation

    Time frame: From the first infusion to the completion of study. Approximately up to 28 months

    Number of Participants with Adverse Events Leading to Discontinuation

  3. Number of Participants With Adverse Events

    Time frame: From the first infusion to the completion of study. Approximately up to 28 months

    Number of Participants with Adverse Events

  4. Number of Participants With Laboratory Abnormalities

    Time frame: From the first infusion to the completion of study. Approximately up to 28 months

    Number of Participants with Laboratory Abnormalities

  5. Number of Participants With Drug Related Laboratory Abnormalities

    Time frame: From the first infusion to the completion of study. Approximately up to 28 months

    Number of Participants with Drug Related Laboratory Abnormalities

Secondary outcomes

  1. Number of Participants With Best Overall Response Per RECIST Criteria

    Time frame: 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

    Best overall response is represented by the number participants who have had complete response, partial response and have stable disease.

  2. Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer

    Time frame: 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

    Best overall response is represented by the number participants who have had complete response, partial response and not completed.

  3. Duration of Overall Response as Per RECIST Criteria

    Time frame: 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

    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).

  4. Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer

    Time frame: 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

    Best overall response is represented by the number participants who have had complete response, partial response and not completed.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 4, 2009
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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