su5416 in treating patients with persistent or recurrent cervical cancer

Conditions: Cervical Cancer

Summary: 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.

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.

Eligibility criteria:
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

Keywords: recurrent cervical cancer cervical squamous cell carcinoma