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Paclitaxel With or Without PSC 833 in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00002937
First received: November 1, 1999
Last updated: January 4, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Breast Cancer
Drug: paclitaxel
Drug: valspodar
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Estimated Enrollment: 70
Study Start Date: June 1996
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Metastatic breast cancer within 2 years of an adjuvant anthracycline based chemotherapy for advanced disease, or failure of one prior anthracycline based chemotherapeutic regimen for advanced breast cancer Exception: When anthracyclines are contraindicated, metastatic disease within 2 years of any adjuvant cytotoxic regimen, or failure of one prior cytotoxic chemotherapeutic regimen for advanced breast cancer also qualifies Evaluable or measurable disease in at least one nonirradiated area No CNS metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 8.0 g/dL Absolute neutrophil count at least 1500/mm3 Hepatic: Total serum bilirubin no greater than 1.5 mg/dL No history of chronic active hepatitis or cirrhosis SGOT and/or SGPT no greater than 2 times the upper limit of normal Renal: Serum creatinine no greater than 2.0 mg/dL Other: Not HIV positive Not pregnant or nursing Effective contraceptive required of fertile patients No uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or bowel obstruction No history of a second malignancy with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix No known hypersensitivity to ingredients of the study medication or cyclosporine No neurologic problems requiring treatment No treatment with drugs within 48 hours that are known to interact with cyclosporine

PRIOR CONCURRENT THERAPY: At least 4 weeks since any investigational therapy Biologic therapy: No concurrent antibiotics, e.g. clarithromycin, erythromycin, nafcillin, rifampin, itraconazole, ketoconazole, or fluconazole (no greater than 200 mg/day allowed) Chemotherapy: No prior paclitaxel At least 6 weeks since nitrosoureas At least 4 weeks since other myelosuppressive chemotherapy Endocrine therapy: At least 2 weeks since hormone therapy No concurrent danazol Radiotherapy: At least 3 weeks since radiation therapy Surgery: Must be recovered from previous surgery Other: No concurrent calcium channel blockers, e.g. diltiazem, nicardipine, and verapamil No concurrent anticonvulsants, e.g. carbamazepine, phenobarbital, and phenytoin No concurrent bromocriptine

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002937

Locations
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
Canada, Ontario
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Study Chair: James H. Doroshow, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002937     History of Changes
Other Study ID Numbers: CDR0000065380, U01CA063265, CHNMC-96002, NCI-H97-1137
Study First Received: November 1, 1999
Last Updated: January 4, 2010
Health Authority: United States: Federal Government

Keywords provided by City of Hope Medical Center:
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014