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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)


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer

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Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Period from study entry until disease progression, death or date of last contact, assessed up to 6 months

Safety Issue:

No

Principal Investigator

Bradley Monk

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02416

NCT ID:

NCT00025233

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Cervical Squamous Cell Carcinoma
  • Recurrent Cervical Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103