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Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075673 |
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vinorelbine with celecoxib may kill more tumor cells.
PURPOSE: Phase I trial to determine the effectiveness of combining vinorelbine with celecoxib in treating women who have relapsed or metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: celecoxib Drug: vinorelbine ditartrate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Weekly Administration of Oral Navelbine in Combination With the COX-2 Inhibitor Celebrex in Relapsed and/or Metastatic Breast Cancer |
Study Start Date: | November 2003 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive oral celecoxib twice daily on days 1-21 and oral vinorelbine on days 7, 14, and 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of celecoxib and vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 12-18 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 confirmed adenocarcinoma of the breast
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
No hypersensitivity to celecoxib
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent administration of any of the following drugs:
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5055 |
Principal Investigator: | Beth A. Overmoyer, MD, FACP | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000347413, CWRU-ICC-3102, GSK-CWRU-ICC-3102 |
Study First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075673 |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IV breast cancer |
Vinorelbine Celecoxib Skin Diseases Breast Neoplasms |
Vinblastine Breast Diseases Recurrence |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Cyclooxygenase Inhibitors Enzyme Inhibitors Antimitotic Agents Pharmacologic Actions Neoplasms Neoplasms by Site |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Tubulin Modulators Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic |