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Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: August 10, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022659
  Purpose

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.

PURPOSE: This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Biological: bevacizumab
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation Of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865, IND #7921) In The Treatment of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2002
Detailed Description:

OBJECTIVES:

  • Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab.
  • Determine the nature and degree of toxicity of this drug in these patients.
  • Determine the progression-free and overall survival of patients treated with this drug.
  • Determine the frequency of clinical response in patients treated with this drug.
  • Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients.
  • Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 55-62 patients will be accrued for this study within 2.2-2.5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal carcinoma

    • Recurrent or persistent after initial standard surgery or chemotherapy
    • Incurable with standard surgery, chemotherapy, or radiotherapy
  • At least 1 unidimensionally measurable target lesion

    • At least 20 mm by conventional techniques
    • At least 10 mm by spiral CT scan
    • Outside the area of prior radiotherapy
  • Accessible to guided core needle biopsy
  • Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease

    • May have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
    • Patients with only 1 prior platinum-based chemotherapy regimen must have an initial treatment-free interval of less than 12 months
    • Patients with an initial treatment-free interval of more than 12 months must have progressive disease after prior platinum-based chemotherapy regimen as second-line therapy
  • No tumors involving major blood vessels
  • No evidence of CNS disease (primary brain tumor or brain metastases) within the past 5 years
  • Ineligible for higher priority GOG protocols (i.e., active phase III GOG protocols for the same patient population)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-2 (patients who have received 1 prior regimen)
  • GOG 0-1 (patients who have received 2 prior regimens)

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No known bleeding disorder or coagulopathy
  • No active bleeding

Hepatic:

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • PT (INR) ≤ 1.5 (INR 2-3 if on stable dose of therapeutic warfarin or low molecular weight heparin)
  • PTT < 1.2 times control

Renal:

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance > 60 mL/min
  • No proteinuria, as indicated by 1 of the following:

    • Negative urine dipstick
    • Urine protein < 30 mg/dL
    • Urine protein < 1,000 mg on 24-hour urine collection

Cardiovascular:

  • No clinically significant cardiovascular disease, including any of the following:

    • Uncontrolled hypertension
    • Myocardial infarction within the past 6 months
    • Unstable angina within the past 6 months
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Peripheral vascular disease ≥ grade 2
  • No stroke within the past 5 years

Other:

  • No pathologic condition that carries a high risk of bleeding
  • No significant traumatic injury within the past 28 days
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No uncontrolled seizures within the past 5 years
  • No neuropathy (motor and sensory) ≥ grade 2
  • No serious non-healing wound, ulcer, or bone fracture
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • No active infection requiring parenteral antibiotics
  • No known claustrophobia that would preclude MRI tolerance
  • No ferromagnetic implants or pacers
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior immunologic therapy directed at malignancy
  • No prior bevacizumab
  • No other concurrent immunotherapy directed at malignancy

Chemotherapy:

  • See Disease Characteristics
  • One additional prior cytotoxic regimen for recurrent or persistent disease allowed
  • No prior non-cytotoxic chemotherapy for recurrent or persistent disease
  • No concurrent chemotherapy directed at malignancy

Endocrine therapy:

  • At least 1 week since prior hormonal therapy directed at malignancy
  • No concurrent hormonal therapy directed at malignancy
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No concurrent radiotherapy directed at malignancy

Surgery:

  • See Disease Characteristics
  • At least 28 days since prior major surgery or open biopsy and recovered
  • At least 7 days since prior core biopsy or placement of vascular access device
  • No anticipated need for major surgical procedure during study participation

Other:

  • At least 3 weeks since other prior therapy directed at malignancy
  • No prior anticancer therapy that would preclude study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022659

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States, 92868
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1740
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Central Illinois
Decatur, Illinois, United States, 62794-9640
CCOP - Evanston
Evanston, Illinois, United States, 60201
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Mississippi
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, United States, 39534-2576
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0526
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
United States, Tennessee
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, United States, 37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-2516
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Robert A. Burger, MD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Han ES, Burger R, Darcy KM, et al.: Relationship between angiogenic markers and clinicopathologic factors/outcome in GOG-170D, a phase II trial of bevacizumab (Bev) in recurrent or persistent epithelial ovarian cancer (EOC) and primary peritoneal cancer (PPC). [Abstract] J Clin Oncol 26 (Suppl 15): A-5577, 2008.
Burger RA, Sill MW, Monk BJ, Greer BE, Sorosky JI. Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Nov 20;25(33):5165-71.

Study ID Numbers: CDR0000068839, GOG-0170D
Study First Received: August 10, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00022659     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Bevacizumab
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Angiogenesis Modulating Agents
Growth Inhibitors
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Growth Substances
Genital Neoplasms, Female
Endocrine System Diseases
Abdominal Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Digestive System Diseases
Peritoneal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009