Completed

PSC 833 and Paclitaxel Combination for Recurrent or Metastatic Breast Cancer

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Study Aim

This study aims to evaluate the effectiveness of combining PSC 833 and Paclitaxel as a treatment for individuals with recurrent or metastatic breast cancer.

What is being tested

paclitaxel

+ valspodar

Drug
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 1997
See protocol details

Summary

Principal SponsorEastern Cooperative Oncology Group
Last updated: June 7, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: August 14, 1997

Actual date on which the first participant was enrolled.

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.

NCT00002826
Principal SponsorEastern Cooperative Oncology Group
Last updated: June 7, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Veterans Affairs Medical Center - Palo Alto

Palo Alto, United StatesOpen Veterans Affairs Medical Center - Palo Alto in Google Maps

Stanford University Medical Center

Stanford, United States

Hunterdon Regional Cancer Program

Flemington, United States

Kimball Medical Center

Lakewood, United States
Completed9 Study Centers