Overview

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