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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002826
Recruitment Status : Completed
First Posted : May 12, 2004
Last Update Posted : August 29, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: paclitaxel Drug: valspodar Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Primary Purpose: Treatment
Official Title: A PILOT PHASE II TRIAL OF PSC 833 MODULATION OF MULTIDRUG RESISTANCE TO PACLITAXEL IN THE TREATMENT OF METASTATIC CARCINOMA OF THE BREAST
Study Start Date : June 1997
Actual Primary Completion Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002826


Locations
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United States, California
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, New Jersey
Hunterdon Regional Cancer Program
Flemington, New Jersey, United States, 08822
Kimball Medical Center
Lakewood, New Jersey, United States, 08701
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Robert W. Carlson, MD Stanford University
More Information
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Publications of Results:
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.

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ClinicalTrials.gov Identifier: NCT00002826    
Other Study ID Numbers: CDR0000065011
E-1195
First Posted: May 12, 2004    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013
Keywords provided by Eastern Cooperative Oncology Group:
stage IV breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action