Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI GOG-0227C NCT00025233

Objectives

1. 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.
2. Determine the nature and degree of toxicity of this drug in these patients.
3. Estimate the distribution of PFS and overall survival for patients treated with this drug.
4. Determine the frequency of clinical response (partial and complete) in patients treated with this drug.
5. Determine the role of age and initial performance status as prognostic factors in patients treated with this drug.
6. Determine whether biological and imaging markers are associated with clinical efficacy of this drug, such as 6-month PFS, in these patients.

Entry 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

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

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/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

A total of 19-51 patients will be accrued for this study within 11-38 months.

Outcomes

Progression-free survival at 6 months
Frequency and severity of adverse effects as assessed by CTC

Duration of progression-free survival and overall survival
Frequency of clinical response (partial and complete response) as assessed by RECIST criteria
Prognostic factors, including initial performance status and age

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Bradley Monk, MD, Protocol chair		Ph: 714-456-7974 Email: bjmonk@uci.edu

Registry Information
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)
Trial Start Date		2002-04-29
Registered in ClinicalTrials.gov		NCT00025233
Date Submitted to PDQ		2001-07-30
Information Last Verified		2006-10-26
NCI Grant/Contract Number		CA27469

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