Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Bevacizumab; Carboplatin; Docetaxel; Gemcitabine; Melphalan; Stem Cell Transplant
Intervention description: 5 mg/kg by vein daily over 90 minutes for 2 Days; 333 mg/m^2 by vein over 2 hours for 3 Days; 300 mg/m^2 by vein over 2 hours for 1 Day; 1,800 mg/m2 by vein over 3 hours for 4 Days; 50 mg/m^2 by vein over 15 minutes for 3 Days; Stem Cell Removal via apheresis through a central venous catheter (CVC), usually in chest
Stem Cell Replacement through CVC over about 30-60 minutes, Day 7 of treatment, following study drug regimen
Intervention MeSH terms: Bevacizumab; Carboplatin; Gemcitabine; Docetaxel; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Epithelial Ovarian Cancer; Bevacizumab; Carboplatin; Gemcitabine; Docetaxel; Melphalan

Summary:

      The goal of this clinical research study is to learn if bevacizumab, when given in
      combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan,
      cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin),
      can help to control ovarian cancer during a stem cell transplant. The safety of this drug
      combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 - <70.

          2. Patients with advanced ovarian, fallopian or primary peritoneal cancer in second or
             later complete remission, or untreated or refractory relapse, defined as relapse
             within 6 months of prior platinum treatment or lack of response to salvage treatment.

          3. No evidence of small bowel obstruction, as determined by CT scan of the abdomen and
             pelvis with oral and rectal contrast, within 30 days before the initiation of study
             treatment.

          4. Adequate renal glomerular and tubular function, as defined by estimated serum
             creatinine clearance >=60 ml/min, and urinary protein excretion <=500 mg/day.

          5. Adequate hepatic function, as defined by serum glutamic oxaloacetic transaminase
             (SGOT), serum glutamic pyruvic transaminase (SGPT) <=3 * upper limit of normal (ULN);
             serum bilirubin and alkaline phosphatase <=2 * ULN or considered not clinically
             significant.

          6. Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced
             vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >=50% of predicted,
             corrected for volume or hemoglobin.

          7. Adequate cardiac function with left ventricular ejection fraction >=45%. No
             uncontrolled arrhythmias or symptomatic cardiac disease.

          8. Zubrod performance status <2.

        Exclusion Criteria:

          1. Failure to collect more than 3 * 10e6 CD34+ stem cells/kg body weight

          2. Patients with unresolved grade 3 or greater non-hematologic toxicity from previous
             therapy. Patients with grade 2 toxicity will be eligible at the discretion of the
             principal investigator.

          3. Major surgery within 30 days before the initiation of study treatment

          4. Radiotherapy within 21 days prior to initiation of study treatment

          5. Patients with active Central Nervous System (CNS) disease.

          6. Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis
             serology, discuss with Principal Investigator and consider liver biopsy.

          7. Uncontrolled infection, including HIV or HTLV-1 infection.

          8. Aspirin (> 325 mg/day) use within 10 days before initiation of study treatment.

          9. Ongoing uncontrolled hypertension (>140/90 mm Hg on medication).

         10. Non-healing wound or significant traumatic injury within 30 days before the initiation
             of study treatment

         11. Previous autologous or allogeneic stem cell transplant during the past year.

         12. Positive Beta HCG test in a woman with child-bearing potential, defined as not
             post-menopausal for 12 months or no previous surgical sterilization.