Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
MeSH terms: Carcinoma; Fallopian Tube Neoplasms
Intervention: Gemcitabine; Oxaliplatin; Bevacizumab
Intervention description: Given intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.; Given intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.; Given intravenously over 30-90 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
Intervention MeSH terms: Bevacizumab; Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mullerian carcinoma

Summary:

      The main purpose of this study is to begin to collect information and try to learn whether or
      not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with
      recurrent mullerian carcinoma. We will also collect more information about the safety and
      side effects of this combination of drugs. Gemcitabine and oxaliplatin are chemotherapy drugs
      that kill cancer cells. Bevacizumab is a new anti-cancer drug that works to slow or stop cell
      growth in cancerous tumors by decreasing the blood supply to the tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic or
             cytologic confirmation of the original primary tumor is required.

          -  Must have measurable disease which is defined as at least one lesion that can be
             accurately measured in at least one dimension. Each lesion must be >20mm when measured
             by conventional techniques.

          -  Must have at least one "target lesion" to be used to assess response.

          -  Platinum-sensitive tumors, defined as a platinum free interval of at least 6 months,
             and may have had up to two prior treatment regimens.

          -  Eastern Cooperative Oncology Group score of 0 or 1

          -  Life expectancy of 12 weeks or longer

          -  18 years of age or older

          -  Adequate bone marrow, renal, neurologic and liver function

          -  Normal blood coagulation parameters

        Exclusion Criteria:

          -  Chemotherapy within last 3 weeks

          -  Current, recent (within 4 weeks), or planned participation in an experimental drug
             study other than a Genentech-sponsored bevacizumab cancer study.

          -  Known bleeding disorder or coagulopathy, or history of stroke.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to study entry or the anticipation of need for major surgical procedure during
             the course of the study.

          -  Minor surgical procedures within 14 days of study entry.

          -  Significant cardiovascular disease, New York Heart Association Grade II or greater
             congestive heart failure, serious cardiac arrhythmia requiring medication, a history
             of deep vein thrombosis, or Grade II or greater, clinically significant peripheral
             vascular disease within 1 year of study entry.

          -  Urine protein:creatinine ration greater than or equal to 1.0

          -  History or clinical evidence of central nervous system disease

          -  Patients with other invasive malignancies, with the exception of non-melanoma skin
             cancer, who have evidence of disease within last three years.

          -  More than 2 prior lines of chemotherapy

          -  Previous treatment with a VEGF targeted inhibitor or antibody

          -  Serious non-healing wound, ulcer or bone fracture

          -  Prior radiation therapy to more than one-third of hematopoietic sites.

          -  History of abdominal fistulas, gastrointestinal perforation, intra-abdominal abscess,
             or partial bowel obstruction within 6 months

          -  Pregnant or lactating