SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer

Study Overview
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Brief Summary
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RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer.

Detailed Description
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OBJECTIVES: Determine the antitumor cytostatic activity of SU5416, in terms of 6-month progression-free survival and time to progression, in patients with persistent or recurrent cervical squamous cell carcinoma. Determine the nature and degree of toxicity of this drug in these patients. Correlate surrogate endpoint molecular and imaging markers with clinical outcome in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 1 hour on days 1 and 4. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 8-23 months.

Official Title
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A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: semaxanib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed cervical squamous cell carcinoma Persistent or recurrent disease with documented progression No nonsquamous cell cervical malignancies, including adenosquamous carcinoma At least 1 measurable lesion At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR At least 10 mm by spiral CT scan Failed prior local therapeutic measures Ineligible for higher priority GOG protocol (e.g., any active GOG phase III protocol for the same patient population) Tumor must be accessible for biopsy using direct- or guided-needle technique PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least lower limit of normal Absolute neutrophil count at least 1,500/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: No uncompensated coronary artery disease on electrocardiogram or physical examination No myocardial infarction within the past 6 months No severe/unstable angina within the past 6 months No severe peripheral vascular disease No deep vein or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: Not pregnant or nursing Fertile patients must use effective contraception Must have central venous access No uncontrolled diabetes mellitus No prior allergic reaction to paclitaxel No active infection requiring antibiotics No peripheral neuropathy greater than grade 1 No contraindications to low-dose (1 mg/day) warfarin or low-molecular weight heparin prophylaxis No claustrophobia that would preclude MRI studies No ferromagnetic implants or pacers No other invasive malignancy within the past 5 years except non-melanoma skin cancer No other concurrent circumstances that would preclude study completion PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: No prior antiangiogenesis agents, including SU5416 At least 3 weeks since prior biologic or immunologic agents directed at malignancy Chemotherapy: No more than 1 prior chemotherapy regimen, including single or combination cytotoxic drug therapy (radiosensitizers do not count as prior regimen) At least 3 weeks since prior chemotherapy directed at malignancy and recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at malignancy Concurrent hormone replacement therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy directed at malignancy and recovered Surgery: See Disease Characteristics At least 3 weeks since prior surgery for malignancy and recovered Other: No prior cancer therapy that would preclude study
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: semaxanib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent cervical cancer, cervical squamous cell carcinoma