Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer
February 2, 2010 updated by: Bristol-Myers Squibb
The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent breast cancer
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
68
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients with primary advanced inoperable disease who were refractory to chemotherapy
- Patients with recurrent disease following post-operative adjuvant chemotherapy
- Patients who were not amenable to post-recurrence chemotherapy
Exclusion Criteria:
- Patients with serious, uncontrolled medical illness
- Patients with previous therapy with taxanes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Paclitaxel
|
Solution, IV, 100 mg/m², weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria
Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
|
Each 49 day course of treatment until withdrawal or unacceptable toxicity
|
|
Safety: incidence and severity of adverse events, laboratory test abnormalities
Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
|
Each 49 day course of treatment until withdrawal or unacceptable toxicity
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer
Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
|
Each 49 day course of treatment until withdrawal or unacceptable toxicity
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
November 30, 2009
First Submitted That Met QC Criteria
November 30, 2009
First Posted (Estimate)
December 2, 2009
Study Record Updates
Last Update Posted (Estimate)
February 4, 2010
Last Update Submitted That Met QC Criteria
February 2, 2010
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA139-371
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.