Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced or metastatic breast cancer
- Bidimensionally measurable disease
- At least one lesion at least 2 cm in one dimension by CT scan or MRI
- Must have failed prior anthracycline/taxane based chemotherapy as defined by one of
the following:
- Stage IV disease treated with anthracycline/taxane combination as first line
therapy for advanced or metastatic disease
- Stage IV disease treated with first line anthracycline therapy and second line
taxane therapy for advanced or metastatic disease
- Any adjuvant treatment other than anthracycline based therapy followed by
anthracycline/taxane combination as first line therapy for advanced or
metastatic disease
- Any adjuvant therapy other than anthracycline based therapy followed by first
line anthracycline based therapy and second line taxane based therapy for
advanced or metastatic disease
- Adjuvant anthracycline based therapy followed by relapse after 6 months treated
with anthracycline/taxane combination as first line therapy or first line
anthracycline based therapy and second line taxane based therapy for advanced or
metastatic disease
- Adjuvant anthracycline based therapy followed by relapse within 6 months treated
with first line taxane based therapy for advanced or metastatic disease
- Disease progression within 6 months of last taxane based chemotherapy
- No brain metastases
- Hormonal receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than
5 times ULN in case of liver metastases)
Renal:
- Creatinine less than 1.25 times ULN
Cardiovascular:
- LVEF at least 50% if prior total dose of doxorubicin 550 mg/m2 or greater, epirubicin
900 mg/m2 or greater, or pirarubicin 700 mg/m2 or greater
- No prior or active congestive heart failure, myocardial infarction, or angina
- No uncontrolled hypertension or arrhythmia
Other:
- No unstable systemic disease
- No active infection
- No grade 2 or greater peripheral neuropathy
- No psychological, familial, sociological, or geographical condition that would
preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior high dose chemotherapy with hematopoietic rescue
- No concurrent immunotherapy
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) for prevention of
neutropenia
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- At least 1 prior taxane based chemotherapy for advanced or metastatic disease
- No prior high dose chemotherapy with hematopoietic rescue
- No prior platinum based chemotherapy
- No prior taxane chemotherapy other than docetaxel or paclitaxel
- No prior adjuvant or neoadjuvant therapy with taxane/anthracycline based combination
chemotherapy
Endocrine therapy:
- No concurrent steroids except in case of allergy prevention, emesis prophylaxis, or
long term treatment for more than 3 months prior to study
- No concurrent hormonal anticancer therapy
Radiotherapy:
- No prior radiotherapy to study site unless evidence of disease progression
- Concurrent local radiotherapy allowed for pain relief
Surgery:
- At least 4 weeks since prior major surgery
Other:
- At least 4 weeks since prior anticancer and/or investigational drug
- No concurrent bisphosphonates unless started at least 2 months prior to study
- No other concurrent anticancer therapy
- No other concurrent experimental drugs