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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00025233
First Posted: January 27, 2003
Last Update Posted: December 7, 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 cancer of the cervix. 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
Cervical Squamous Cell Carcinoma Recurrent Cervical 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 Trial of Bevacizumab (rhuMAB VEGF) (NSC #704865) in the Treatment of Persistent and Recurrent Squamous Cell Carcinoma of the Cervix (Group A)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free Survival Greater Than 6 Months [ Time Frame: Every other 3-week treatment cycle for 6 months ]
    Whether or not the patient survived progression-free for at least 6 months.

  • Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 [ Time Frame: Every cycle and 30 days after the end of treatment. ]
    The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.


Secondary Outcome Measures:
  • Tumor Response [ Time Frame: Every other cycle during treatment and at the time of treatment discontinuation. ]
    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.

  • 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 during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 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.

  • Performance Status [ Time Frame: Baseline ]
    Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.

  • Age at Enrollment [ Time Frame: Baseline ]

Enrollment: 50
Study Start Date: April 2002
Study Completion Date: July 2009
Primary Completion Date: July 2009 (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 3 weeks 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:

OBJECTIVES:

I. 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.

II. Determine the nature and degree of toxicity of this drug in these patients. III. Estimate the distribution of PFS and overall survival for patients treated with this drug.

IV. Determine the frequency of clinical response (partial and complete) in patients treated with this drug.

V. Determine the role of age and initial performance status as prognostic factors in patients treated with this drug.

VI. 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

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 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
  • 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
  • Performance status - GOG 0-2 (if received 1 prior regimen)
  • Performance status - GOG 0-1 (if received 2 prior regimens)
  • 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
  • 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
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 60 mL/min
  • No proteinuria

    • Urine protein < 1+ on dipstick or < 30 mg/dL
    • Urine protein < 1000 mg by 24-hour urine collection
  • 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
  • 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
  • No prior bevacizumab
  • At least 3 weeks since prior immunologic agents for SCC of the cervix
  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior non-cytotoxic chemotherapy for persistent or recurrent disease
  • At least 1 week since prior hormonal therapy for SCC of the cervix
  • Concurrent hormone replacement therapy allowed
  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • 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
  • 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
  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): NCT00025233


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025233     History of Changes
Other Study ID Numbers: NCI-2012-02416
NCI-2012-02416 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068940
GOG-0227C ( Other Identifier: Gynecologic Oncology Group )
GOG-0227C ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: October 11, 2001
First Posted: January 27, 2003
Results First Submitted: June 10, 2015
Results First Posted: June 29, 2015
Last Update Posted: December 7, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Bevacizumab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors