Clinical Trial: Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix

This study has been suspended.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 cancer of the cervix.

Condition Treatment or Intervention Phase
recurrent cervical cancer
cervical squamous cell carcinoma
 Drug: bevacizumab
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: growth factor antagonist therapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bevacizumab in Patients With Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

Further Study Details: 

OBJECTIVES:

  • Determine the cytostatic antitumor activity of bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with persistent or recurrent squamous cell carcinoma of the cervix.
  • Determine the nature and degree of toxicity of this drug in these patients.
  • Estimate the distribution of PFS and overall survival for patients treated with this drug.
  • Determine the frequency of clinical response (partial and complete) in patients treated with this drug.
  • Determine the role of age and initial performance status as prognostic factors in patients treated with this drug.
  • Determine whether biological and imaging markers are associated with clinical efficacy of this drug, such as 6-month PFS, in these patients.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks 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 19-51 patients will be accrued for this study within 11-38 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed persistent or recurrent squamous cell carcinoma (SCC) of the cervix
  • Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix
  • Chemotherapy administered as a radio-sensitizer does not count as 1 regimen
  • Documented disease progression
  • At least 1 unidimensionally measurable lesion*
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Tumors within a previously irradiated field are considered nontarget lesions unless documented evidence of progressive disease or biopsy-confirmed persistent disease at least 90 days after completion of radiotherapy
  • No tumor involving major blood vessels
  • No history or physical evidence of CNS disease, including primary or metastatic brain tumor
  • Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active GOG phase III protocol for the same patient population

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • GOG 0-2 (if received 1 prior regimen)
  • GOG 0-1 (if 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 other active bleeding or pathologic condition that would confer a high risk of bleeding

Hepatic:

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • INR ≤ 1.5 (or 2-3 for patients on a 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
  • Urine protein < 1+ on dipstick or < 30 mg/dL OR
  • Urine protein < 1000 mg by 24-hour urine collection

Cardiovascular:

  • No clinically significant cardiovascular disease
  • No uncontrolled hypertension
  • No myocardial infarction or unstable angina within the past 6 months
  • No New York Heart Association grade II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No grade II or greater peripheral vascular disease
  • No history of stroke within the past 5 years

Other:

  • No greater than grade 1 sensory or motor neuropathy
  • No active infection requiring parenteral antibiotics
  • No serious nonhealing wound, ulcer, or bone fracture
  • No history or physical evidence of seizures not controlled with standard medical therapy
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
  • No significant traumatic injury within the past 4 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • No prior bevacizumab
  • At least 3 weeks since prior immunologic agents for SCC of the cervix

Chemotherapy:

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior non-cytotoxic chemotherapy for persistent or recurrent disease

Endocrine therapy:

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery:

  • Recovered from recent prior surgery
  • At least 4 weeks since prior major surgical procedure or open biopsy
  • At least 1 week since prior placement of vascular access device or core biopsy
  • No concurrent major surgical procedure

Other:

  • At least 3 weeks since other prior therapy for SCC of the cervix
  • No prior anticancer therapy that would preclude study therapy
  • No concurrent anticoagulants other than those required to maintain the patency of indwelling IV catheters
  • No concurrent chronic daily aspirin greater than 325 mg/day or other nonsteroidal anti-inflammatory medications that are known to inhibit platelet function at doses used for chronic inflammatory diseases

Location Information


Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States

California
      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868-3298,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States

Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States

      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States

      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States

Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States

Mississippi
      Keesler Medical Center - Keesler Air Force Base, Keesler AFB,  Mississippi,  39534-2576,  United States

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States

Ohio
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0526,  United States

      Mount Carmel West Hospital, Columbus,  Ohio,  43222,  United States

Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States

Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States

      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States

South Dakota
      Obstetrics and Gynecology and Gynecologic Oncology, P.C., Sioux Falls,  South Dakota,  57105,  United States

Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States

      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States

      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States

Study chairs or principal investigators

Bradley J. Monk, MD,  Study Chair,  Chao Family Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068940; GOG-0227C; NCT00025233
Record last reviewed:  February 2005
Last Updated:  February 17, 2005
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025233
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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