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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00971867
• Collaborator: (none)
• Enrollment: 11
• Locations: 9
• Arm: 1
• Actual Duration (Months): 27.8
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: Paclitaxel	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
• Actual Study Start Date: Aug 4, 2006
• Actual Primary Completion Date: Nov 26, 2008
• Actual Study Completion Date: Nov 26, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paclitaxel	Drug: Paclitaxel; 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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With SAEs [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 [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 [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 [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 [From the first infusion to the completion of study. Approximately up to 28 months]

   Number of Participants with Drug Related Laboratory Abnormalities

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Kashiwa-shi	Chiba	Japan	2778577
2	Local Institution	Matsuyama-shi	Ehime	Japan
3	Local Institution	Kagoshima-shi	Kagoshima	Japan	8900075
4	Local Institution	Yokohama	Kanagawa	Japan	241-0815
5	Local Institution	Osaka-shi	Osaka	Japan	5458586
6	Local Institution	Sunto-gun	Shizuoka	Japan	4118777
7	Local Institution	Meguro-ku	Tokyo	Japan	1520021
8	Local Institution	Kanagawa		Japan
9	Local Institution	Tochigi		Japan	329-0498

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00971867
• Other Study ID Numbers: CA139-539
• First Posted: Sep 4, 2009
• Last Update Posted: Apr 8, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Head and Neck Neoplasms; Paclitaxel

Study Results

Participant Flow

Pre-assignment Detail	11 Participants Treated

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Period Title: Overall Study
STARTED	11
COMPLETED	0
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 63.6%
>=65 years	4 36.4%
Sex: Female, Male (Count of Participants)
Female	2 18.2%
Male	9 81.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	0 0%
Unknown or Not Reported	11 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	11 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Measure Participants	11
Number [Number of Participants]	3 27.3%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Measure Participants	11
Number [Number of Participants]	5 45.5%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Measure Participants	11
Number [Number of Participants]	11 100%

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Measure Participants	11
Number [Number of Participants]	11 100%

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Measure Participants	11
Number [Number of Participants]	11 100%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Measure Participants	11
Complete Response (CR)	1 9.1%
Partial Response (PR)	6 54.5%
Stable Disease (SD)	4 36.4%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Measure Participants	11
Complete Response (CR)	1 9.1%
Partial Response (PR)	9 81.8%
Not Completed	1 9.1%

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Measure Participants	11
Median (Full Range) [Days]	222

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539

Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
Measure Participants	10
Median (Full Range) [Days]	269

Adverse Events

Time Frame	From the first infusion to the completion of study. Approximately up to 28 months
Arm/Group Title	Paclitaxel
Arm/Group Description	Each vial (16.7 mL) contains 100 mg
All Cause Mortality
	Paclitaxel
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Serious Adverse Events
	Paclitaxel
	Affected / at Risk (%)	# Events
Total	3/11 (27.3%)
Gastrointestinal disorders
Vomitting	1/11 (9.1%)	1
General disorders
Cancer Pain	1/11 (9.1%)	1
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease	1/11 (9.1%)	1
Dyspnea	1/11 (9.1%)	1
Other (Not Including Serious) Adverse Events
	Paclitaxel
	Affected / at Risk (%)	# Events
Total	11/11 (100%)
General disorders
Fatigue	7/11 (63.6%)
Weight Disorder	5/11 (45.5%)
Nail Disorder	5/11 (45.5%)
Nervous system disorders
Hypoesthesia	9/11 (81.8%)
Skin and subcutaneous tissue disorders
Alopecia	11/11 (100%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.