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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039520 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining sulindac with docetaxel in treating women who have metastatic or recurrent breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: docetaxel Drug: sulindac |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast |
Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: Patients receive oral sulindac twice daily. Patients also receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed within 3-4 weeks.
PROJECTED ACCRUAL: Approximately 12-33 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
Measurable disease
No carcinomatous meningitis and/or untreated or uncontrolled brain parenchymal disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
One of the following:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 |
Study Chair: | Mary Cianfrocca, DO | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000069390, FCCC-01031, FCCC-63723, NCI-G02-2080 |
Study First Received: | June 6, 2002 |
Last Updated: | October 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00039520 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Anti-Inflammatory Agents Skin Diseases Cyclooxygenase Inhibitors Breast Neoplasms Sulindac sulfone Recurrence Docetaxel Analgesics, Non-Narcotic |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Sulindac Analgesics Antirheumatic Agents Adenocarcinoma Breast Diseases |
Anti-Inflammatory Agents Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Breast Neoplasms Enzyme Inhibitors Pharmacologic Actions Docetaxel Neoplasms |
Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Sulindac Antirheumatic Agents Central Nervous System Agents Breast Diseases |