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A PILOT PHASE II TRIAL OF PSC 833 MODULATION OF MULTIDRUG RESISTANCE TO PACLITAXEL IN THE TREATMENT OF METASTATIC CARCINOMA OF THE BREAST


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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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 CenterBronx, New York  10461
Stanford University Medical CenterStanford, California  94305-5408
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
St. Francis Medical CenterTrenton, New Jersey  08629
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Hunterdon Regional Cancer ProgramFlemington, New Jersey  08822
Kimball Medical CenterLakewood, New Jersey  08701