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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00038012
Eligibility Criteria:
INCLUSION CRITERIA:
* Patients with gynecologic malignancy for whom treatment with carboplatin is indicated.
* Age \>/= 15 years.
* Adequate hematologic, renal, and hepatic functions.
* Life expectancy \>/- 3 months. Karnofsky Performance Status \>/= 80.
* Signed informed consent form.
EXCLUSION CRITERIA:
* Patients with rapidly progressive disease.
* Pregnant or lactating women.
* Patients with comorbid condition which renders patients at high risk of treatment complication.
* History of CNS metastasis.
* Patients with significant cardiac disease (NYHA Class III or IV), dysrhythmia, or recent history of MI or ischemia, transient ischemic attack or CVA within the 6 months of study entry.
* Prior chemotherapy, immunotherapy, any experimental drug within 4 weeks, use of myeloid (G-CSF or GM-CSF) growth factors within 2 weeks or erythropoietin within 4 weeks.
* Use of any nitrosourea (BCNU, CCNU) or mitomycin - C within 6 weeks.
* Prior surgery or RT within 2 wks of study entry.
* Patients with history of prior high dose chemotherapy with stem cell transplant or with history of prolonged thrombocytopenia (\> 2 weeks).
* History of leukemia.
* History of any platelet disorders including ITP, TTP or bleeding disorders.
* History of \> 3 prior chemotherapy regimens (all platinum regimens will be counted as 1 regimen).
* Demonstrated lack of response to platinum-based therapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Study:
NCT00038012
Study Brief:
Protocol Section:
NCT00038012