Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer
Inclusion Criteria:
- Histologically proven dx of recurrent or metastatic breast cancer
- Must have received at least 1 but not more than 3 prior chemotherapy regimens
for recurrent or metastatic breast cancer. Patients who relapse within 12 months of
completing adjuvant chemotherapy can only have had up to 2 prior regimens for
metastatic disease. Patients who relapse within 12 months of completing adjuvant
chemotherapy containing an anthracycline and a taxane, do not require prior
chemotherapy for metastatic disease.
- Unidimensionally measurable dz (by RECIST)
- At least 18 yrs of age
- SWOG PS 0-2
- AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb
greater than or equal to 8.0
- Total bilirubin less than or equal to 2 x uln; SGOT and/or SGPT and alk phos up to
2.5 x uln
- Creatinine less than or equal to 2.0
- Fully recovered from acute toxicities secondary to prior tx
- Signed informed consent (including HIPAA authorization)
- Peripheral neuropathy grade 0-1
Exclusion Criteria
- Prior tx with gemcitabine or oxaliplatin. Prior tx with cisplatin or carboplatin
allowed if completed >12 mos prior to enrollment.
- Underlying medical, psychiatric, or social conditions that would preclude patient
from receiving tx
- Peripheral neuropathy greater than or equal to Gr 2
Exclusion Criteria:
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