Paclitaxel With or Without PSC 833 in Treating Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00002937|
Recruitment Status : Completed
First Posted : September 3, 2004
Last Update Posted : January 6, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel with or without PSC 833 in treating patients with metastatic breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: paclitaxel Drug: valspodar||Phase 2|
OBJECTIVES: I. Evaluate the response rate and time to treatment failure of paclitaxel with and without the P-glycoprotein (Pgp) antagonist PSC 833 in advanced breast cancer. II. For each treatment arm, relate paclitaxel AUC (area under curve), and/or time above .05 um/L, to myelosuppression and/or response. III. To obtain preliminary estimates of MDR in this group of patients by measuring MDR1-Pgp immunostaining in pretreatment biopsies in 20 patients and biopsies taken at the time of progression.
OUTLINE: This is a randomized study. Patients are stratified according to three criteria: 1) treatment within 2 years of adjuvant chemotherapy vs. progression on chemotherapy for advanced disease 2) measurable vs. evaluable disease 3) institution. Patients receive paclitaxel alone or paclitaxel plus PSC 833. In the first arm, paclitaxel alone is administered by continuous infusion over 3 hours once every 3 weeks. In the second arm, PSC 833 is administered PO four times a day for 3 days; paclitaxel is administered by continuous infusion over 3 hours on day 2. Courses repeat every 3 weeks.
PROJECTED ACCRUAL: Approximately 70 patients will be accrued per year in this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Official Title:||A Phase II Randomized Study of Paclitaxel Versus Paclitaxel + PSC833 for Advanced Breast Cancer (Recurring Less Than 6 Months Since Adjuvant or as Second Line for Advanced Disease|
|Study Start Date :||June 1996|
|Primary Completion Date :||November 2005|
|Study Completion Date :||November 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002937
|United States, California|
|Beckman Research Institute, City of Hope|
|Duarte, California, United States, 91010|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Toronto Sunnybrook Regional Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Study Chair:||James H. Doroshow, MD||City of Hope Comprehensive Cancer Center|