A Phase II Study of Carboplatin in Combination With Gemcitabine as a Dose Dense Schedule in Patients With Locally Advanced or Metastatic Breast Cancer That Are Resistant to Anthracyclines & Taxanes
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Locally advanced or metastatic disease
- Recurrent or refractory disease
- Histological or cytological confirmation required for recurrence in a solitary
site
- Must have received prior anthracycline and taxane as neoadjuvant, adjuvant, or
metastatic therapy
- Measurable disease*
- At least 1 measurable site of disease, defined as ≥ 1 unidimensionally
measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT
scan
- Palpable disease allowed NOTE: *Lesions that have been irradiated in the
advanced setting cannot be included as sites of measurable disease
- No nonmeasurable disease only, including the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Inflammatory breast disease
- Lymphangitic pulmonary disease
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- No HER2-positive disease, defined as 3+ by IHC OR positive by FISH or chromogenic in
situ hybridization
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- ECOG performance status 0-1
- Estimated life expectancy ≥ 12 weeks
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after
completion of study therapy
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- ALT or AST < 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine ≤ 1.25 times ULN OR creatinine clearance > 40 mL/min
- Calcium ≤ 1.2 times ULN
- No concurrent serious medical or psychiatric illness, including any serious active
infection incompatible with the study
- No other primary malignancy except carcinoma in situ of the cervix, adequately
treated nonmelanomatous skin cancer, or any other malignancy previously treated ≥ 5
years ago with no evidence of recurrence
- No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior chemotherapy
- Prior hormonal therapy or immunotherapy allowed
- Antitumoral hormonal therapy must be discontinued prior to study entry
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to the whole pelvis or to ≥ 25% of the bone marrow
- No prior gemcitabine hydrochloride, cisplatin, or carboplatin
- No other cytotoxic chemotherapy for 21 days before and for 14 days after completion
of study therapy
- More than 30 days since prior treatment with a drug (not including study drug) that
has not received regulatory approval for any indication at the time of study entry
- Bisphosphonate therapy may not be initiated or discontinued within 4 weeks of study
entry
- No more than 1 prior course of chemotherapy for metastatic disease
- Prior chemotherapy in the adjuvant setting allowed
- Concurrent palliative radiotherapy to existing painful lesions (soft tissue or bone)
allowed
- New bone pain requiring radiotherapy > 4 weeks after first study treatment
considered disease progression
- New pain in a soft tissue lesion without other objective changes may be
irradiated provided ≥ 1 other site of nonirradiated measurable disease exists
- No other concurrent anticancer treatment
- No concurrent tamoxifen citrate, aromatase inhibitors, or progestagens