Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer
Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel works in treating patients with refractory metastatic breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 2 months until disease progression and then every 6 months thereafter.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
Previously treated with chemotherapy in the adjuvant setting and/or for metastatic disease
At least one unidimensionally measurable lesion
At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan
Superficial clinical lesions (e.g., skin nodules or palpable lymph nodes) are allowed
Lesions on chest x-ray are allowed provided they are clearly defined and surrounded by aerated lung
The following are not considered measurable:
No known CNS metastases unless controlled by prior surgery and/or radiotherapy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin ≤ upper limit of normal (ULN)
Meets 1 of the following criteria:
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
See Disease Characteristics
More than 14 days since prior chemotherapy
No more than 2 prior chemotherapy regimens for metastatic disease
No prior irinotecan or docetaxel for metastatic disease
No other concurrent chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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