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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00022659
First Posted: January 27, 2003
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  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: Intervention Model: Single Group Assignment
Masking: None (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 at 6 Months [ Time Frame: Every other cycle for 6 months. ]
    Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

  • Tumor Response [ Time Frame: Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years. ]
    RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

  • To Determine the Nature and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC. [ Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years. ]
    The observed length of life from entry into the study to death or the date of last contact.

  • Duration of Progression-free Survival [ Time Frame: Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years. ]
    Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.


Enrollment: 64
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 Gynecologic Oncology Group (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)
  • serum glutamate oxaloacetate transaminase (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)
  • Partial thromboplastin time (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022659


Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert Burger Gynecologic Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022659     History of Changes
Other Study ID Numbers: NCI-2012-02400
NCI-2012-02400 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068839
GOG-0170D ( Other Identifier: Gynecologic Oncology Group )
GOG-0170D ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2001
First Posted: January 27, 2003
Results First Submitted: April 23, 2015
Results First Posted: May 12, 2015
Last Update Posted: December 11, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian 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
Bevacizumab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors