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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT00086892
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial or primary peritoneal cancer
* Recurrent disease
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan
* Target lesion not within previously irradiated field
* Received 1 prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound
* Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
* Patients who had not received prior paclitaxel therapy may have received a second regimen that included paclitaxel
* Platinum-sensitive disease
* Treatment-free interval without clinical evidence of progressive disease for more than 6 months after response to a prior platinum-based regimen
* If there is another concurrently active GOG-0146 series protocol (non-platinum-based therapy), must have had a treatment-free interval of more than 12 months unless ineligible for the other protocol\* NOTE: \*Applies whether or not both protocols are available at the same participating center
* Must have available tissue block or unstained sections from primary tumor, interval debulking, or secondary debulking
* Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No uncontrolled hypertension
* No unstable angina
* No congestive heart failure
* No uncontrolled arrhythmias within the past 6 months
* No other significant cardiac disease
Neurologic
* No uncontrolled seizure disorder
* No active neurological disease
* No neuropathy \> grade 1
Other
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No active infection requiring antibiotics
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
* No prior chimerized or murine monoclonal antibody therapy
* At least 3 weeks since prior biologic or immunologic therapy for the malignancy
Chemotherapy
* See Disease Characteristics
* Recovered from prior chemotherapy
* No prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimens
Endocrine therapy
* At least 1 week since prior hormonal therapy for the malignancy
* Concurrent hormone replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
* No prior radiotherapy to \> 25% of bone marrow-bearing areas
Surgery
* More than 30 days since prior major surgery and recovered
* Diagnostic biopsy not considered major surgery
Other
* At least 3 weeks since other prior therapy for the malignancy
* No prior tyrosine kinase inhibitors that target the EGFR pathway
* No prior cancer treatment that would preclude study treatment
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00086892
Study Brief:
Protocol Section:
NCT00086892