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Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
This study has been completed.
First Received: October 11, 2001   Last Updated: August 8, 2009   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025233
  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 Intervention Phase
Cervical Cancer
Biological: bevacizumab
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Bevacizumab (rhuMAB VEGF) (NSC #704865 IND #7921) 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 at 6 months [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by CTC [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
  • Frequency of clinical response (partial and complete response) as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Prognostic factors, including initial performance status and age [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: April 2002
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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 older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  • At least 1 week since prior hormonal therapy for SCC of the cervix
  • Concurrent hormone replacement therapy allowed

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025233

  Show 41 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Bradley J. Monk, MD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068940, GOG-0227C
Study First Received: October 11, 2001
Last Updated: August 8, 2009
ClinicalTrials.gov Identifier: NCT00025233     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer
cervical squamous cell carcinoma

Study placed in the following topic categories:
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Bevacizumab
Squamous Cell Carcinoma
Angiogenesis Inhibitors
Recurrence
Carcinoma
Uterine Cervical Neoplasms
Genital Diseases, Female
Uterine Cervical Diseases
Epidermoid Carcinoma
Uterine Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

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

ClinicalTrials.gov processed this record on September 02, 2009