Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

Completed · Phase 2

Conditions studied: Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma

In brief

The purpose of this study is to evaluate the effectiveness and tolerability of the combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life is during their treatment.

Key facts

Study ID

NCT00407563

Run by

Accelerated Community Oncology Research Network

People needed

48

Starts

2007-01-01

Expected to finish

2011-02-01

Last updated by the study team

2012-04-05

Who can join

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

You may qualify if…

• Measurable disease by CT or MRI.
• At least 1 "target lesion" to be used to assess response as defined by GOG RECIST criteria.
• ECOG performance status of 0 or 1.
• Patient provides voluntary written informed consent.
• At least 18 years of age.
• Negative serum pregnancy test.
• Recovered from any recent surgery for at least 30 days and is free of active infection.
• Received the following prior therapy at time of enrollment:
• Must have had 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin or organoplatinum. Initial therapy may have included high-dose therapy, consolidation, or extended therapy. Patient should be defined as recurrent or progression of disease within 6 months of last platinum chemotherapy.
• May have had 1 additional cytotoxic or non-cytotoxic chemotherapy regimen.
• Must have adequate hematologic and hepatic function.

You may not qualify if…

• Previously received bevacizumab.
• History of other invasive malignancy with the exception of nonmelanoma skin cancer.
• ECOG performance status of 2, 3, or 4.
• 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 bevacizumab cancer study. Patient must be bevacizumab naïve.
• Blood pressure of >150/100 mm Hg on antihypertensive medications.
• Prior history of hypertensive crisis or hypertensive encephalopathy.
• Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart failure.
• History of myocardial infarction within 6 months of enrollment.
• History of stroke or transient ischemic attack within 6 months prior to study enrollment.
• Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection)or symptomatic peripheral vascular disease.
• Bleeding diathesis or coagulopathy.
• Presence of CNS or brain metastases.
• Pre-existing peripheral neuropathy of Grade ≥ 2.
• A 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.
• A partial or complete small or large bowel obstruction demonstrated radiologically within 3 months prior to study enrollment.
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
• Positive pregnancy test or is lactating.
• History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
• Serious, non-healing wound, ulcer, or bone fracture.
• Serious intercurrent medical or psychiatric illness, including serious active infection.
• Inability to comply with study and/or follow-up procedures.
• Life expectancy of less than 12 weeks.
• Proteinuria at screening as demonstrated by either:
• Urine protein:creatinine (UPC) ratio ≥ 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).

Where it is running

• Little Rock Hematology Oncology — Little Rock, Arkansas, United States
• Wilshire Oncology Medical Group, Inc. — La Verne, California, United States
• Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
• Southeastern Gynecologic Oncology, LLC — Atlanta, Georgia, United States
• North Idaho Cancer Center — Coeur d'Alene, Idaho, United States
• Hematology-Oncology Centers of the Northern Rockies — Billings, Montana, United States
• Mid-Ohio Oncology/Hematology — Columbus, Ohio, United States
• Pennsylvania Oncology Hematology Assoc. — Philadelphia, Pennsylvania, United States
• Chattanooga's Program in Women's Oncology — Chattanooga, Tennessee, United States
• The West Clinic — Memphis, Tennessee, United States
• Cancer Specialists of Tidewater, Ltd — Chesapeake, Virginia, United States

Full record on ClinicalTrials.gov

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