- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003540
Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel
Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol
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.
Study Overview
Detailed Description
OBJECTIVES:
- Determine the objective response rate to gemcitabine in women with metastatic breast cancer previously treated with two to four chemotherapy regimens, including doxorubicin and paclitaxel.
- Characterize the nature of toxicity of gemcitabine in this patient population.
- Determine the response duration to gemcitabine in this patient population.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic breast cancer
Bidimensionally measurable disease
- No bone scan abnormalities alone
- Lytic lesions in conjunction with bone scan abnormalities allowed
- No pure blastic bone metastases
- No pleural or peritoneal effusions
- No previously irradiated lesions
- Must have received 2-4 prior chemotherapy regimens, including paclitaxel and doxorubicin, for breast cancer
Brain metastases allowed if other measurable disease exists
- No uncontrolled or life threatening brain lesions
- No carcinomatous meningitis
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- AST/ALT no greater than 5 times upper limit of normal
Renal:
- Calcium no greater than 11.0 mg/dL
Other:
- Not pregnant
- Negative pregnancy test
- No history of other malignancy except carcinoma in situ of the cervix or curatively treated nonmelanoma skin cancer
- No other serious medical illnesses, including severe infection and severe malnutrition
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- Prior hormonal therapies for stage IV disease and/or adjuvant therapy allowed
- At least 3 weeks since prior hormonal therapy
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to greater than 30% of the marrow bearing bone
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy to the only measurable lesion
Surgery:
- Recovered from prior surgery
- No concurrent surgery to the only measurable lesion
Other:
- No concurrent nonprotocol treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Violante E. Currie, MD, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- 98-030
- CDR0000066594 (Registry Identifier: PDQ (Physician Data Query))
- NCI-G98-1474
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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