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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT00049556
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial cancer or cervical cancer (open to accrual for cervical cancer patients only as of 4/5/2005)
* Relapsed or refractory
* The following are also eligible: (open to accrual for cervical cancer patients only as of 4/5/2005)
* Cancer of the fallopian tube
* Primary peritoneal cancer
* Cancer with low malignant potential and an invasive recurrence
* Block or recuts of primary tumor or recent resection specimen of a metastatic site required
* Measurable disease with a sentinel lesion adequate for core biopsy by percutaneous biopsy or laparoscopy
* No CNS involvement
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* Bilirubin less than 1.5 mg/dL
* AST and ALT no greater than 2.5 times upper limit of normal
Renal
* Creatinine less than 1.5 mg/dL
Cardiovascular
* No myocardial infarction within the past 6 months
* No unstable dysrhythmia within the past 6 months
Other
* No other invasive malignancy within the past 5 years except noninvasive nonmelanoma skin cancer
* No active ocular inflammation or infection
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior cetuximab or monoclonal antibody ABX-EGF
Chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
* At least 4 weeks since prior hormonal therapy and recovered
* No concurrent tamoxifen
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
Surgery
* Recovered from prior oncologic or other major surgery
Other
* No prior epidermal growth factor receptor inhibitory agents (e.g., OSI-774)
* No concurrent antiretroviral therapy
* No concurrent itraconozole, ketoconazole, erythromycin, verapamil, chlorpromazine, amiodarone, or chloroquine
* No concurrent drugs known to induce CYP3A4 enzymes (e.g., phenytoin, carbamazepine, rifampicin, barbiturates, oxacarbazepine, rifapentine, or Hypericum perforatum)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00049556
Study Brief:
Protocol Section:
NCT00049556