Pharmacokinetic Study of Avastin and Doxil in Ovarian Cancer

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is to study pharmacokinetics of Doxil using Doxil and Avastin on ovarian cancer patients who are resistant to or have relapsed from platinum-based therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: Genentech, Inc.; University of New Mexico; University of New Mexico Cancer Center
• Treatments: Bevacizumab; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Patients must be platinum resistant

• No prior anthracycline use

• PS ≤ 2

• Lab values within certain limits (ANC > 1000, platelets > 100,000; ALT, AST 2x ULN, creatinine < 2.0);

• No more than 3 prior chemotherapy regimens, only 2 of which can have included platinum-containing regimens.

• Use of effective means of contraception in subjects of child-bearing potential

Exclusion Criteria:

• Disease-Specific Exclusions:

• Evidence of complete or partial bowel obstruction

• Need for IV hydration or TPN

• > 2 prior abdominal surgeries

• History of gastrointestinal perforation

• Gastrointestinal perforation due to any other cause within the last 6 months

• General Medical Exclusions:

• Inability to comply with study and/or follow-up procedures

• Life expectancy of less than 12 weeks

• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study

• Avastin-Specific Exclusions:

• Inadequately controlled hypertension (defined as systolic blood pressure greater than 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)

• Any prior history of hypertensive crisis or hypertensive encephalopathy

• New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E of the protocol)

• History of myocardial infarction or unstable angina within 6 months prior to study enrollment

• History of stroke or transient ischemic attack within 6 months prior to study enrollment

• Known CNS disease

• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

• Symptomatic peripheral vascular disease

• Evidence of bleeding diathesis or coagulopathy

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study

• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment

• History of abdominal fistula, or intra-abdominal abscess within 6 months prior to study enrollment

• Serious, non-healing wound, ulcer, or bone fracture

• Proteinuria at screening as demonstrated by either

• Urine protein:creatinine (UPC) ratio no less than 1.0 at screening OR

• Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).

• Known hypersensitivity to any component of Avastin

• Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential