A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Gemcitabine; Oxaliplatin
Intervention description: Gemcitabine 1000mg/m^2 on day 1 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal; Oxaliplatin 100mg/m^2 on day 2 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic breast cancer

Summary:

      The purpose of this study is to investigate if the combination of gemcitabine and oxaliplatin
      is effective for triple negative breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed ER-, PR-, Her2neu- (Triple Negative)
             metastatic breast cancer

          -  Patients must have measurable disease according to the RECIST criteria. Patients with
             bone metastases may be included if they have a decrease in performance status or
             narcotic analgesic requirement.

          -  Patients must have either received a taxane in the adjuvant setting or received a
             taxane as first-line treatment for metastatic breast cancer

          -  Age > 18 years

          -  ECOG Performance Score of 0, 1, or 2 (Appendix A)

          -  Adequate bone marrow as evidenced by:

          -  Absolute neutrophil count > 1,500/L

          -  Platelet count > 100,000/microL

          -  Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL

          -  Adequate hepatic function as evidenced by:

               -  Serum total bilirubin < 1.5 mg/dL

               -  Alkaline phosphatase < 3X the ULN for the reference lab < 5X the ULN (Upper limit
                  for normal) for patients with known hepatic metastases

               -  SGOT/SGPT < 3X the ULN(Upper limit for normal) for the reference lab (< 5X the
                  ULN for patients with known hepatic metastases

          -  Patients must be recovered from both acute and late effects of any prior surgery,
             radiotherapy or other antineoplastic therapy

          -  Patients or their legal representatives must be able to read, understand and provide
             informed consent to participate in the trial.

          -  Patients of childbearing potential agree to use an effective form of contraception
             during the study and for 90 days following the last dose of study medication (an
             effective form of contraception is an oral contraceptive or a double barrier method)

        Exclusion Criteria:

          -  Patients with an active infection or with a fever > 101.30 F within 3 days of the
             first scheduled day of protocol treatment

          -  Patients with active CNS metastases. Patients with stable CNS disease, who have
             undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment
             and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the
             trial

          -  History of prior malignancy within the past 5 years except for curatively treated
             basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized
             prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations at least
             3 months apart, with the most recent evaluation within 4 weeks of entry

          -  Patients with known hypersensitivity to any of the components of oxaliplatin or
             gemcitabine.

          -  Patients who have received gemcitabine or platin-based chemotherapy in the past.

          -  Patients who have received chemotherapy within 28 days of the first scheduled day of
             protocol treatment.

          -  Patients who received radiotherapy to more than 25% of their bone marrow; or patients
             who received any radiotherapy within 4 weeks of entry

          -  Patients who are receiving concurrent investigational therapy or who have received
             investigational therapy within 28 days of the first scheduled day of protocol
             treatment (investigational therapy is defined as treatment for which there is
             currently no regulatory authority approved indication)

          -  Peripheral neuropathy Grade 2

          -  Patients who are pregnant or lactating

          -  Any other medical condition, including mental illness or substance abuse, deemed by
             the Investigator to be likely to interfere with a patient's ability to sign informed
             consent, cooperate and participate in the study, or interfere with the interpretation
             of the results.

          -  History of allogeneic transplant

          -  Known HIV or Hepatitis B or C (active, previously treated or both)