Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol
18 Years
N/A
Female
Breast Cancer
Trial Information
Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Violante E. Currie, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
98-030
NCT ID:
NCT00003540
Start Date:
June 1998
Completion Date:
November 2002
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
