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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971867
• Other study ID #: CA139-539
• Status: Completed
• Phase: Phase 2
• Start date: August 4, 2006
• Est. completion date: November 26, 2008

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 26, 2008
• Est. primary completion date: November 26, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Local Institution	Kagoshima-shi	Kagoshima
Japan	Local Institution	Kanagawa
Japan	Local Institution	Kashiwa-shi	Chiba
Japan	Local Institution	Matsuyama-shi	Ehime
Japan	Local Institution	Meguro-ku	Tokyo
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Sunto-gun	Shizuoka
Japan	Local Institution	Tochigi
Japan	Local Institution	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With SAEs	Number of Participants with SAEs	From the first infusion to the completion of study. Approximately up to 28 months
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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