Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022659
First received: August 10, 2001
Last updated: June 10, 2014
Last verified: December 2012
  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. 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.


Condition Intervention Phase
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Biological: bevacizumab
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865) 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):

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency and duration of objective response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by CTC [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Duration of overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: April 2002
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (bevacizumab)
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.
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab.

II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug.

IV. Determine the frequency of clinical response in patients treated with this drug.

V. Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients.

VI. 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.

  Eligibility

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

Inclusion Criteria:

  • 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)
  • Performance status - GOG 0-2 (patients who have received 1 prior regimen)
  • Performance status - GOG 0-1 (patients who have received 2 prior regimens)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No known bleeding disorder or coagulopathy
  • No active bleeding
  • 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
  • Creatinine ≤ 1.5 times ULN
  • 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
  • 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
  • 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
  • At least 3 weeks since prior immunologic therapy directed at malignancy
  • No prior bevacizumab
  • No other concurrent immunotherapy directed at malignancy
  • 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
  • At least 1 week since prior hormonal therapy directed at malignancy
  • No concurrent hormonal therapy directed at malignancy
  • Concurrent hormone replacement therapy allowed
  • Recovered from prior radiotherapy
  • No concurrent radiotherapy directed at malignancy
  • 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
  • At least 3 weeks since other prior therapy directed at malignancy
  • No prior anticancer therapy that would preclude study entry
  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: NCT00022659

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Robert Burger Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022659     History of Changes
Other Study ID Numbers: NCI-2012-02400, NCI-2012-02400, CDR0000068839, GOG-0170D, GOG-0170D, U10CA027469
Study First Received: August 10, 2001
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014