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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With SAEs
Number of Participants with SAEs
Number of Participants With Adverse Events Leading to Discontinuation
Number of Participants with Adverse Events Leading to Discontinuation
Number of Participants With Adverse Events
Number of Participants with Adverse Events
Number of Participants With Laboratory Abnormalities
Number of Participants with Laboratory Abnormalities
Number of Participants With Drug Related Laboratory Abnormalities
Number of Participants with Drug Related Laboratory Abnormalities

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
September 3, 2009
Last Updated
February 16, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00971867
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 4, 2006 (Actual)
Primary Completion Date
November 26, 2008 (Actual)
Study Completion Date
November 26, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, BMS-181339
Intervention Description
Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Primary Outcome Measure Information:
Title
Number of Participants With SAEs
Description
Number of Participants with SAEs
Time Frame
From the first infusion to the completion of study. Approximately up to 28 months
Title
Number of Participants With Adverse Events Leading to Discontinuation
Description
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
Title
Number of Participants With Adverse Events
Description
Number of Participants with Adverse Events
Time Frame
From the first infusion to the completion of study. Approximately up to 28 months
Title
Number of Participants With Laboratory Abnormalities
Description
Number of Participants with Laboratory Abnormalities
Time Frame
From the first infusion to the completion of study. Approximately up to 28 months
Title
Number of Participants With Drug Related Laboratory Abnormalities
Description
Number of Participants with Drug Related Laboratory Abnormalities
Time Frame
From the first infusion to the completion of study. Approximately up to 28 months
Secondary Outcome Measure Information:
Title
Number of Participants With Best Overall Response Per RECIST Criteria
Description
Best overall response is represented by the number participants who have had complete response, partial response and have stable disease.
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
Title
Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Description
Best overall response is represented by the number participants who have had complete response, partial response and not completed.
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
Title
Duration of Overall Response as Per RECIST Criteria
Description
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).
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
Title
Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Description
Best overall response is represented by the number participants who have had complete response, partial response and not completed.
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution
City
Matsuyama-shi
State/Province
Ehime
Country
Japan
Facility Name
Local Institution
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
8900075
Country
Japan
Facility Name
Local Institution
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
Local Institution
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
4118777
Country
Japan
Facility Name
Local Institution
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
1520021
Country
Japan
Facility Name
Local Institution
City
Kanagawa
Country
Japan
Facility Name
Local Institution
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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