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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00138151
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically and/or cytologically confirmed cervical cancer, meeting 1 of the following criteria:
* Stage IVB disease
* Recurrent disease
* Persistent disease
* Patients previously treated with chemoradiotherapy as initial therapy must demonstrate disease progression
* Measurable disease by physical exam or radiographic studies
* Not amenable to chemoradiotherapy or surgery
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2
Life expectancy
* At least 6 months
Hematopoietic
* WBC ≥ 3,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* SGOT and SGPT ≤ 2 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 50 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* No active infection
* No medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior interferon
* No other concurrent immunotherapy
Chemotherapy
* See Disease Characteristics
* At least 3 months since prior chemoradiotherapy (6 weeks for patients experiencing disease progression after completion of initial chemoradiotherapy)
* No other prior chemotherapy
Endocrine therapy
* No concurrent hormonal therapy for cancer
Radiotherapy
* See Disease Characteristics
* See Chemotherapy
* Recovered from prior radiotherapy
* No concurrent radiotherapy
Surgery
* Recovered from prior surgery
* No concurrent surgery for cancer
Other
* No prior retinoids
* No other concurrent anticancer therapy
* No other concurrent experimental agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00138151
Study Brief:
Protocol Section:
NCT00138151