Overview
Drug Resistance Inhibition in Treating Women With Recurrent or Metastatic Breast Cancer
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
RATIONALE: Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with a chemotherapy drug may reduce resistance to the drug, and allow the tumor cells to be killed. PURPOSE: Phase II trial to study the effectiveness of PSC 883 and paclitaxel in treating women who have recurrent or metastatic breast cancer.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Eastern Cooperative Oncology GroupCollaborator:
National Cancer Institute (NCI)Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast that isrecurrent 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