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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

Phase 2
Not Enrolling
Breast Cancer

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Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

James H. Doroshow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

June 1996

Completion Date:

November 2005

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • Breast Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Beckman Research Institute, City of Hope Los Angeles, California  91010
University of California Davis Cancer Center Sacramento, California  95817