Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT00026260
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
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00026260
Study Brief:
Protocol Section:
NCT00026260