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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00971867

Enrollment

Registered

2009-09-04

Start date

2006-08-04

Completion date

2008-11-26

Last updated

2022-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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

Interventions

DRUGPaclitaxel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
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).
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.
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.

Countries

Japan

Participant flow

Pre-assignment details

11 Participants Treated

Participants by arm

Arm	Count
Paclitaxel Each vial (16.7 mL) contains 100 mg	11
Total	11

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	4
Overall Study	Disease Progression	6
Overall Study	Participant Withdrew Consent	1

Baseline characteristics

Characteristic	Paclitaxel
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	4 Participants
Age, Categorical Between 18 and 65 years	7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants
Race (NIH/OMB) White	0 Participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	9 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 11
other Total, other adverse events	11 / 11
serious Total, serious adverse events	3 / 11

Outcome results

Primary