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Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Celgene Corporation
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00407563
First received: December 4, 2006
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Drug: Bevacizumab
Drug: Abraxane
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Bevacizumab With Abraxane in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Accelerated Community Oncology Research Network:

Primary Outcome Measures:
  • 6-month Progression-Free Rate [ Time Frame: 6 months after initiation of study treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Best Overall Response [ Time Frame: Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months. ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    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.

  • Best Overall Response at Six Months [ Time Frame: Assessed over 6 months of study treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: January 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle.
    Other Name: Avastin
    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.
    Other Name: albumin-bound paclitaxel
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407563

Locations
United States, Arkansas
Little Rock Hematology Oncology
Little Rock, Arkansas, United States, 72205
United States, California
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States, 91750
United States, Georgia
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
Southeastern Gynecologic Oncology, LLC
Atlanta, Georgia, United States, 30342
United States, Idaho
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States, 38314
United States, Montana
Hematology-Oncology Centers of the Northern Rockies
Billings, Montana, United States, 59101
United States, Ohio
Mid-Ohio Oncology/Hematology
Columbus, Ohio, United States, 43219
United States, Pennsylvania
Pennsylvania Oncology Hematology Assoc.
Philadelphia, Pennsylvania, United States, 19106
United States, Tennessee
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, United States, 37403
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Virginia
Cancer Specialists of Tidewater, Ltd
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Accelerated Community Oncology Research Network
Genentech, Inc.
Celgene Corporation
Investigators
Principal Investigator: Lee S. Schwartzberg, MD, FACP The West Clinic
  More Information

No publications provided by Accelerated Community Oncology Research Network

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00407563     History of Changes
Other Study ID Numbers: ACORN ALSSOPR0501
Study First Received: December 4, 2006
Results First Received: September 28, 2011
Last Updated: March 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Bevacizumab
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014