Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
Condition: Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: carboplatin; Bevacizumab; Paclitaxel
Intervention description: Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.; Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.; 60-80 mg/m2 administered on Day 1, 8 & 15 during cycle 1-3. Treatment cycle consists of 21 days duration.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: bevacizumab; paclitaxel; carboplatin; ovarian; cancer; fallopian tube; primary peritoneal

Summary:

      The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous
      weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with
      epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive
      neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo
      surgery which will allow an objective measure of response to the above regimen as well as
      assessment of surgical outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian
             tube cancer

          -  FIGO (International Federation of Gynecology and Obstetrics stage III or IV disease

          -  GOG (Gynecologic Oncology Group) Performance Status 0,1,2

          -  No prior surgery for their malignancy

          -  Adequate bone marrow function

          -  Platelet count greater than or equal to 100,000

          -  Renal Function: Creatinine < 1.5 institutional upper limit normal

          -  Hepatic Function: Bilirubin less than 1.5 ULN (upper limit of normal)

          -  Hepatic Function: SGOT (serum glutamate oxaloacetate transaminase) and Alkaline
             Phosphate

          -  Neurologic Function: Neuropathy less than CTCAE (Common Toxicity Criteria for Adverse
             Effects)grade 1

          -  Coagulation Functions: INR<1.5 and PTT ,1.2 times the upper limit of normal

          -  Measurable disease

        Exclusion Criteria:

          -  Previous cancer related surgery

          -  Received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or biologic
             therapy for their ovarian, fallopian tube or primary peritoneal cancer.

          -  Borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer
             or non-epithelial ovarian are not eligible.

          -  Other cancers within 5 years (other than non-melanoma skin cancer)

          -  Acute Hepatitis or end stage liver disease

          -  History of prior gastrointestinal perforation

          -  Evidence of abdominal free air not explained by paracentesis

          -  Sign or symptoms of gastrointestinal obstruction

          -  Active bleeding or pathologic conditions that carry high risk of bleeding

          -  CNS (Central Nervous System) disease

          -  Clinically Significant cardiovascular disease

          -  Known hypersensitivity to Chinese Hamster ovary cell products or other recombinant
             human or humanized antibodies

          -  Clinically significant proteinuria.

          -  Hypertensive crises or hypertensive encephalopathy

          -  History of hemoptysis

          -  Any non-study related invasive procedure within 28 days fo first date of bevacizumab

          -  GOG performance status 3 or 4

          -  Patients who are pregnant or nursing.

          -  Under the age of 18

          -  Received prior treatment of bevacizumab or any anti-VEGF (vascular endothelial growth
             factor) drug