Clinical trial NCT00971867: Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
Official title: Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With SAEs
timeFrame: From the first infusion to the completion of study. Approximately up to 28 months
measure: Number of Participants With Adverse Events Leading to Discontinuation
timeFrame: From the first infusion to the completion of study. Approximately up to 28 months
measure: Number of Participants With Adverse Events
timeFrame: From the first infusion to the completion of study. Approximately up to 28 months
measure: Number of Participants With Laboratory Abnormalities
timeFrame: From the first infusion to the completion of study. Approximately up to 28 months
measure: Number of Participants With Drug Related Laboratory Abnormalities
timeFrame: From the first infusion to the completion of study. Approximately up to 28 months
Secondary outcomes:
measure: Number of Participants With Best Overall Response Per RECIST Criteria
timeFrame: 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
measure: Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
timeFrame: 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
measure: Duration of Overall Response as Per RECIST Criteria
timeFrame: 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
measure: Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
timeFrame: 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
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: Local Institution
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Local Institution
state: Ehime
city: Kagoshima-shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Yokohama
country: Japan
facility: Local Institution
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Sunto-gun
country: Japan
facility: Local Institution
state: Shizuoka
city: Meguro-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Kanagawa
country: Japan
facility: Local Institution
city: Tochigi
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: