Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer
A Phase 2 Study of Bevacizumab With Abraxane in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma
1 other identifier
interventional
48
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2007
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2006
CompletedFirst Posted
Study publicly available on registry
December 5, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
April 5, 2012
CompletedApril 5, 2012
March 1, 2012
4.1 years
December 4, 2006
September 28, 2011
March 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
6-month Progression-Free Rate
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 Outcomes (4)
Best Overall Response
Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.
Overall Survival
Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.
Progression-free Survival (PFS)
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
Assessed over 6 months of study treatment
Interventions
Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle.
Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Eligibility Criteria
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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Accelerated Community Oncology Research Networklead
- Genentech, Inc.collaborator
- Celgene Corporationcollaborator
Study Sites (11)
Little Rock Hematology Oncology
Little Rock, Arkansas, 72205, United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91750, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Southeastern Gynecologic Oncology, LLC
Atlanta, Georgia, 30342, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, 38314, United States
Hematology-Oncology Centers of the Northern Rockies
Billings, Montana, 59101, United States
Mid-Ohio Oncology/Hematology
Columbus, Ohio, 43219, United States
Pennsylvania Oncology Hematology Assoc.
Philadelphia, Pennsylvania, 19106, United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, 37403, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Cancer Specialists of Tidewater, Ltd
Chesapeake, Virginia, 23320, United States
Related Publications (1)
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.
PMID: 22960352DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President of Scientific Affairs
- Organization
- Accelerated Community Oncology Research Network, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Lee S. Schwartzberg, MD, FACP
The West Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2006
First Posted
December 5, 2006
Study Start
January 1, 2007
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
April 5, 2012
Results First Posted
April 5, 2012
Record last verified: 2012-03