Drug Resistance Inhibition in Treating Women With Recurrent or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00002826

Recruitment Status : Completed

First Posted : May 12, 2004

Last Update Posted : August 29, 2013

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Eastern Cooperative Oncology Group

Tracking Information

First Submitted Date ^ICMJE

November 1, 1999

First Posted Date ^ICMJE

May 12, 2004

Last Update Posted Date

August 29, 2013

Study Start Date ^ICMJE

June 1997

Actual Primary Completion Date

November 2003 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Drug Resistance Inhibition in Treating Women With Recurrent or Metastatic Breast Cancer

Official Title ^ICMJE

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

Brief 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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: paclitaxel
Drug: valspodar

Study Arms ^ICMJE

Not Provided

Publications *

Carlson RW, O'Neill A, Goldstein L, et al.: A phase II trial of PSC-833 modulation of multidrug resistance to paclitaxel in breast cancer: a pilot trial of the Eastern Cooperative Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-234, 2002.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Study Completion Date ^ICMJE

Not Provided

Actual Primary Completion Date

November 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

Female

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00002826

Other Study ID Numbers ^ICMJE

CDR0000065011
E-1195

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Not Provided

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Original Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Robert W. Carlson, MD

Stanford University

PRS Account

Eastern Cooperative Oncology Group

Verification Date

August 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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