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 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT00004866
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced or recurrent squamous cell carcinoma of the cervix not curable by surgery or radiotherapy
* Measurable disease
* No known brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No active congestive heart failure
* No uncontrolled angina
* No myocardial infarction within the past 6 months
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent serious infection
* No other malignancy within the past 5 years except nonmelanomatous skin cancer
* No other life threatening illness
* No psychosis, mental disability, or incompetence
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent biologic therapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy
* No more than 1 prior chemotherapy regimen (except chemotherapy for radiosensitization)
* No prior camptothecin
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* At least 4 weeks since prior surgery
* No concurrent surgery
Other:
* At least 4 weeks since other prior investigational drugs (including analgesics or antiemetics)
* No other concurrent investigational drugs during or within 28 days after final dose of study drug
* No concurrent drugs that induce or inhibit CYP3A enzyme
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00004866
Study Brief:
Protocol Section:
NCT00004866