Cervical Cancer
Conditions
Keywords
recurrent cervical cancer, cervical squamous cell carcinoma
Brief 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.
Detailed description
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.
Interventions
DRUGsemaxanib
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion 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
Outcome results
None listed