Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

NCT ID: NCT00407563

Last Updated: 2012-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-02-28

Brief Summary

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.

Conditions

Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Bevacizumab

Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle.

Intervention Type: DRUG

Abraxane

Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.

Intervention Type: DRUG

Other Intervention Names

Avastin; albumin-bound paclitaxel

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).
• Known hypersensitivity to any component of bevacizumab.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Accelerated Community Oncology Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee S. Schwartzberg, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

The West Clinic

Locations

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

Countries

United States

References

Tillmanns TD, Lowe MP, Walker MS, Stepanski EJ, Schwartzberg LS. Phase II clinical trial of bevacizumab with albumin-bound paclitaxel in patients with recurrent, platinum-resistant primary epithelial ovarian or primary peritoneal carcinoma. Gynecol Oncol. 2013 Feb;128(2):221-8. doi: 10.1016/j.ygyno.2012.08.039. Epub 2012 Sep 5.

Reference Type: DERIVED

PMID: 22960352 (View on PubMed)

Other Identifiers

ACORN ALSSOPR0501

Identifier Type: -

Identifier Source: org_study_id