Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

March 8, 2012 updated by: Accelerated Community Oncology Research Network

A Phase 2 Study of Bevacizumab With Abraxane in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Hematology Oncology
    • California
      • La Verne, California, United States, 91750
        • Wilshire Oncology Medical Group, Inc.
    • Georgia
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care, LLC
      • Atlanta, Georgia, United States, 30342
        • Southeastern Gynecologic Oncology, LLC
    • Idaho
      • Coeur d'Alene, Idaho, United States, 38314
        • North Idaho Cancer Center
    • Montana
      • Billings, Montana, United States, 59101
        • Hematology-Oncology Centers of the Northern Rockies
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Mid-Ohio Oncology/Hematology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Oncology Hematology Assoc.
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga's Program in Women's Oncology
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Cancer Specialists of Tidewater, Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month Progression-Free Rate
Time Frame: 6 months after initiation of study treatment
Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
6 months after initiation of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response
Time Frame: Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.
Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.
Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.
Overall Survival
Time Frame: Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.
Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.
Progression-free Survival (PFS)
Time Frame: PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.
Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.
Best Overall Response at Six Months
Time Frame: Assessed over 6 months of study treatment
The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.
Assessed over 6 months of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Accelerated Community Oncology Research Network

Collaborators

Genentech, Inc.
Celgene Corporation

Investigators

  • Principal Investigator: Lee S. Schwartzberg, MD, FACP, The West Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 5, 2006

Study Record Updates

Last Update Posted (Estimate)

April 5, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACORN ALSSOPR0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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