A PILOT PHASE II TRIAL OF PSC 833 MODULATION OF MULTIDRUG RESISTANCE TO PACLITAXEL IN THE TREATMENT OF METASTATIC CARCINOMA OF THE BREAST
18 Years
N/A
Female
Breast Cancer
Trial Information
A PILOT PHASE II TRIAL OF PSC 833 MODULATION OF MULTIDRUG RESISTANCE TO PACLITAXEL IN THE TREATMENT OF METASTATIC CARCINOMA OF THE BREAST
OBJECTIVES: I. Evaluate the antitumor activity, as measured by frequency of objective
response and time to progression, of the multidrug resistance modulator PSC 833 in
combination with paclitaxel in women with recurrent or metastatic breast cancer. II.
Describe the toxicity of this regimen.
OUTLINE: All patients receive PSC 833 by mouth every 6 hours for a total of 12 doses.
Paclitaxel is infused over 3 hours, after the 5th dose of PSC 833. Treatment is repeated
every 3 weeks in stable and responding patients. PSC 833 must not be mixed with grapefruit
juice. Growth factors may be used at the discretion of the investigator. Patients are
followed every 3 months for the first two years, then every 6 months for years 2-5, and then
annually thereafter.
PROJECTED ACCRUAL: It is anticipated that approximately 36 patients will be entered over 24
months if there are at least 6 responses in the first 17 patients.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast that is
recurrent or metastatic No CNS metastases Bidimensionally measurable disease required
Patients with bone sites only are not eligible Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Women only Menopausal status: Not specified
Performance status: ECOG 0-2 Hematopoietic: Platelet count at least 100,000/mm3 Absolute
granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST less
than 2.5 times upper limit of normal Renal: Creatinine no greater than twice upper limit
of normal Other: No allergy to cyclosporine or to drugs formulated with Cremophor (e.g.,
some anesthetics and muscle relaxants) No active unresolved infection More than 7 days
since parenteral antibiotics No second malignancy within 5 years except: In situ cervical
cancer Nonmelanomatous skin cancer No pregnant or nursing women Adequate contraception
required of fertile women
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior
anthracyclines or medical contraindication to anthracycline therapy required No prior
paclitaxel or taxotere No more than 1 prior regimen for metastatic or recurrent disease
Adjuvant chemotherapy within 6 months of diagnosis of metastatic disease considered
therapy for advanced disease At least 3 weeks since chemotherapy Endocrine therapy: At
least 3 weeks since hormonal therapy for metastases Radiotherapy: Not specified Surgery:
Not specified Other: No concurrent treatment with any of the following agents proven to
affect blood levels of cyclosporine: Diltiazem Nicardipine Verapamil Fluconazole
Itraconazole Ketoconazole Clarithromycin Erythromycin Methylprednisolone Prednisolone
Allopurinol Bromocriptine Danazol Metoclopramide Nafcillin Rifampin Carbamazepine
Phenobarbital Phenytoin Octreotide Ticlopidine
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Robert W. Carlson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Stanford University
Authority:
United States: Federal Government
Study ID:
CDR0000065011
NCT ID:
NCT00002826
Start Date:
June 1997
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County | Mount Holly, New Jersey 08060 |
| St. Francis Medical Center | Trenton, New Jersey 08629 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
| Hunterdon Regional Cancer Program | Flemington, New Jersey 08822 |
| Kimball Medical Center | Lakewood, New Jersey 08701 |
