Pharmacokinetic Study of Avastin and Doxil in Ovarian Cancer

Completed · Phase 1

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00846612

Run by

NYU Langone Health

People needed

15

Starts

2008-01-01

Expected to finish

2012-06-01

Last updated by the study team

2019-09-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univ. of New Mexico cancer research and treatment center — Albuquerque, New Mexico, United States
• Bellevue Hospital — New York, New York, United States
• NYU Cancer Center — New York, New York, United States
• NYU medical center (Tisch Hospital) — New York, New York, United States

Full record on ClinicalTrials.gov

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