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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00680758 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with everolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin, paclitaxel, and everolimus when given together in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: cisplatin Drug: everolimus Drug: paclitaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of Cisplatin, Paclitaxel, and RAD001 Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 18 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1 hour and paclitaxel IV over 1 hour on days 1, 8, and 15. Patients receive oral everolimus on days 1, 8, 15, and 21. Courses repeat every 4 weeks in the absence of disease progression and unaccepted toxicity.
After completion of study therapy, patients are followed at 4 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive mammary carcinoma
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to:
PRIOR CONCURRENT THERAPY:
No more than 4 prior chemotherapy regimens in the metastatic setting
Study ID Numbers: | CDR0000586902, VU-VICC-BRE-0770 |
Study First Received: | May 18, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00680758 |
Health Authority: | Unspecified |
male breast cancer stage IV breast cancer |
Everolimus Cisplatin Skin Diseases Breast Neoplasms, Male |
Paclitaxel Breast Neoplasms Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |