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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT00036751
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed epithelial carcinoma of the ovary or primary peritoneal serous papillary carcinoma
* No mixed Mullerian tumors
* No borderline ovarian tumors
* Stage III or IV disease at time of diagnosis by surgical staging
* Expression of KIT (CD117) and/or platelet-derived growth factor receptor by immunohistochemistry
* Relapsed within 6 months after completion of or progressed while receiving prior frontline chemotherapy with a platinum (cisplatin or carboplatin) and a taxane(paclitaxel or docetaxel) administered concurrently or sequentially
* Measurable disease
* Performance status - Zubrod 0-1
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL (transfusion allowed)
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN
* Creatinine no greater than 1.5 times ULN
* No New York Heart Association class III or IV heart disease (e.g., congestive heart failure or myocardial infarction within the past 2 months)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after study participation
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
* At least 28 days since prior biologic therapy
* No concurrent anticancer biologic therapy
* No concurrent cytokines (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
* At least 28 days since prior chemotherapy
* No more than 3 prior chemotherapy regimens in addition to frontline chemotherapy
* Retreatment with a platinum agent or with the same taxane as in the frontline regimen is not counted as an additional regimen
* No concurrent chemotherapy
* Prior hormonal therapy allowed
* Recovered from prior radiotherapy
* No prior radiotherapy to more than 25% of bone marrow
* No concurrent radiotherapy
* Prior surgical debulking allowed for relapsed disease if measurable disease remains after surgery
* At least 14 days since prior major surgery
* Recovered from all prior surgery
* At least 28 days since prior investigational drugs
* No concurrent therapeutic doses of warfarin for anticoagulation (heparin or mini-dose warfarin (1 mg/day) allowed)
* No other concurrent anticancer agents
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00036751
Study Brief:
Protocol Section:
NCT00036751