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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025233
First received: October 11, 2001
Last updated: June 10, 2014
Last verified: January 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 [ Time Frame: Period from study entry until disease progression, death or date of last contact, assessed up to 6 months ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: Period from study entry until disease progression, death or date of last contact, assessed up to 7 years ] [ Designated as safety issue: No ]
  • Duration of overall survival [ Time Frame: Length of life from entry into the study to death or the date of last contact, up to 7 years ] [ Designated as safety issue: No ]
  • Frequency of clinical response (partial and complete response) as assessed by Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Performance status and age [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 51
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

Ages Eligible for Study:   18 Years and older
Genders 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
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: NCT00025233

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

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025233     History of Changes
Other Study ID Numbers: NCI-2012-02416, NCI-2012-02416, CDR0000068940, GOG-0227C, GOG-0227C, U10CA027469
Study First Received: October 11, 2001
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014