Study of Bevacizumab/Doxil in Treatment of Platinum-Resistant/Refractory Ovarian Cancer (CA)

Completed · Phase 2

Conditions studied: Ovarian Cancer

In brief

The purpose of this research study is to test the safety, tolerability, and effectiveness of two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin). How Doxil is metabolized and excreted from the body will also be studied.

Key facts

Study ID

NCT00945139

Run by

New Mexico Cancer Research Alliance

People needed

46

Starts

2007-03-01

Expected to finish

2011-08-01

Last updated by the study team

2015-07-31

Who can join

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

You may qualify if…

• Patients must be platinum resistant
• Patients will be included in the study based on the following criteria:
• No prior anthracycline use
• PS less or equal 2
• Lab values within certain limits (ANC greater 1000, platelets greater 100,000; ALT, AST 2 time ULN, creatinine less 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
• Greater 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 150 and/or diastolic blood pressure greater 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)
• 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

• University of New Mexico — Albuquerque, New Mexico, United States
• New Mexico Cancer Care Associates — Santa Fe, New Mexico, United States
• New York University Cancer Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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