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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT00101192
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous or non-squamous cell carcinoma of the cervix
* Advanced, persistent, or recurrent disease
* Documented disease progression
* Not amenable to curative therapy
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* At least 1 target lesion
* Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy to confirm persistence
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No significant history of cardiac disease within the past 6 months, including the following:
* Unstable angina
* Uncontrolled hypertension
* Uncontrolled congestive heart failure
* Uncontrolled arrhythmia
Neurologic
* No uncontrolled seizure disorder
* No active neurological disease
* No neuropathy (sensory and motor) \> grade 1
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
* No prior chimerized or murine monoclonal antibody therapy
Chemotherapy
* Not specified
Endocrine therapy
* At least 1 week since prior anticancer hormonal therapy
* Concurrent hormone replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
Surgery
* More than 30 days since prior major surgery, except diagnostic biopsy
Other
* Recovered from all prior therapy
* No prior cytotoxic therapy for cervical cancer
* No prior tyrosine kinase inhibitor therapy that targets the EGFR pathway
* No prior cancer treatment that would contraindicate study therapy
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00101192
Study Brief:
Protocol Section:
NCT00101192