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:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT00003369
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed squamous or adenosquamous carcinoma of the cervix that is metastatic, recurrent, or refractory Any stage disease treated with prior radical surgery and/or definitive radiotherapy that has locally recurred and is no longer amenable to surgery or radiotherapy OR Metastatic disease that is not amenable to surgery or radiation therapy Measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 times upper limit of normal Other: No history of allergic reaction to mannitol Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other prior malignancy except: Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer from which the patient is currently in complete remission Any other cancer from which the patient has been disease free for 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factor therapy Chemotherapy: Prior chemotherapy (hydroxyurea, fluorouracil, metronidazole, cisplatin, or other platinum agent) allowed as a radiosensitizing agent only No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy allowed to less than 30% of the bone marrow only Recovered from toxic effects No concurrent radiotherapy Surgery: See Disease Characteristics Prior surgery allowed Recovered from effects of prior surgery Other: No prior systemic therapy for this disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00003369
Study Brief:
Protocol Section:
NCT00003369