Clinical trial NCT00583622 (phase 2, status: terminated)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: bevacizumab, carboplatin, docetaxel, gemcitabine, melphalan
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, N[C@@H](CCCNC(N)=N)C(O)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O
Reason stopped: 
    slow accrual
  
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.