Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Bevacizumab; Carboplatin; Docetaxel; Gemcitabine; Melphalan

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.