A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Paclitaxel; Gemcitabine; Avastin
Intervention description: Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.; Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.; 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.
Intervention MeSH terms: Paclitaxel; Gemcitabine; Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer

Summary:

      The purpose of this study is to look at a new chemotherapy schedule in metastatic breast
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be 18 years of age or older with histologically confirmed breast cancer
             and clinical evidence of metastatic disease.

          -  Patients must have measurable or non-measurable disease. X-rays, scans or physical
             examinations used to assess measurable disease must be performed within 28 days prior
             to registration. X-rays, scans or physical examinations to assess non-measurable
             disease must be completed within 42 days prior to registration. Patients with
             effusions or ascites as the only sites of disease are ineligible.

          -  Patients must meet the following requirements regarding prior and concurrent
             chemotherapy:Patients must not have received prior chemotherapy regimens for
             metastatic breast cancer. Patients may have received adjuvant/neoadjuvant
             chemotherapy, for a total of 3 prior regimens.

          -  Prior therapy with paclitaxel or docetaxel is allowed in the adjuvant or neoadjuvant
             setting, if given > 6 months prior to registration.

          -  Patients must have >14 days delay between the conclusion of any radiation and the
             start of gemcitabine, provided the acute effects of radiation treatment have resolved.

          -  Patients may have received any number of exogenous hormonal therapies and/or
             trastuzumab in the adjuvant, neoadjuvant or metastatic setting. Last dose of prior
             hormonal therapy at least 14 days prior to registration.

          -  Patients may receive concomitant bisphosphonate therapy for bone metastasis.

          -  Patients must have recovered from any prior surgery. Two weeks must have elapsed from
             the time of any minor surgery and 4 weeks of any major surgery.

          -  Patients must have adequate bone marrow reserve as evidenced by the following: ANC >
             1500/mcL, platelets > 100, 000/mcL, and hemoglobin > 9.0 gm/dL. These results must be
             obtained within 28 days prior to registration.

          -  Patients must have serum creatinine < 1.5 mg/dL, obtained within 28 days prior to
             registration.

          -  Urine Protein: creatinine ratio ≥ 1.0 at screening.

          -  Patients must have adequate liver function.

          -  Patients must have a Zubrod performance status of 0-1.

        Exclusion Criteria:

          -  Patients must not have tumors that carry HER-2 gene amplifications as determined by
             (i) fluorescence in situ hybridization (FISH) or (ii) overexpression of HER-2 protein
             3+ level assessed by immunohistochemistry; or may have tumors that carry HER=2 gene
             amplification and have had disease progression while on trastuzumab. Patients who have
             previously been treated with trastuzumab must be off treatment at least 28 days prior
             to registration.

          -  Patients must not have CNS metastasis, leptomeningeal disease or lymphatic pulmonary
             metastases.

          -  Patients must not have had prior therapy with gemcitabine or bevacizumab.

          -  Patient must not have major surgical procedure, open biopsy, or significant traumatic
             injury within 28 days prior to start of treatment, anticipation of need for major
             surgical procedure during the course of the study.

          -  Patients must not have received radiation to > 50% of the marrow-bearing bone.

          -  Patients must not have a history of significant symptomatic cardiac disease or left
             ventricular ejection fraction (LVEF) < 50% of the institutional lower limit of normal
             (ILLN). An isotope cardiac scan (MUGA) and ECG must be obtained within 28 days.

          -  Patients with uncontrolled hypertension are NOT eligible (BP>150/100).

          -  Patients must not have pr-existing clinically significant (Grade 2 or greater per
             CTCAE Version 3.0 motor or sensory neuropathy except for abnormalities due to cancer.

          -  Patients known to be HIV positive.

          -  Patients must not be nursing or pregnant. Men and women of reproductive potential must
             agree to use an effective contraceptive method.

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             Stage I or Stage II cancer from which the patient has been disease free for 5 years.

          -  Patients must not have had a Stroke or Myocardial Infarction in the past 6 months.
             Patients with unstable agina, significant peripheral vascular disease, history of
             abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the
             last 6 months should be excluded.