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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: | NCT00074139 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them at different times, may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/mIV On The Combination Therapy Doxorubicin (50 mg/m) And Cyclophosphamide (50 mg/m) In The Treatment Of Advanced Breast Cancer |
Study Start Date: | September 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients are followed at 3-4 weeks.
PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this study within 7 months.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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: | CDR0000343609, CWRU-040314, CWRU-AVEN-1103, AVENTIS-XRP6976D/1001 |
Study First Received: | December 10, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00074139 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Skin Diseases Immunologic Factors Breast Neoplasms Cyclophosphamide Immunosuppressive Agents Recurrence Doxorubicin |
Docetaxel Anti-Bacterial Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |