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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003540 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 1998 |
OBJECTIVES:
OUTLINE: Patients receive gemcitabine IV over 30 minutes once weekly for 3 consecutive weeks (days 1, 8, and 15) followed by 1 week of rest. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxic effects.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 13 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Bidimensionally measurable disease
Brain metastases allowed if other measurable disease exists
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Violante E. Currie, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000066594, MSKCC-98030, NCI-G98-1474 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003540 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Antimetabolites Radiation-Sensitizing Agents Immunologic Factors Skin Diseases Paclitaxel Breast Neoplasms |
Gemcitabine Immunosuppressive Agents Antiviral Agents Doxorubicin Breast Diseases Recurrence |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine Breast Diseases |