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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00157560
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed epithelial carcinoma of müllerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.
* Patients must have undergone an attempt at aggressive surgical debulking or alternatively be eligible for interim debulking after cycle #3. Patients debulked to no evidence of disease, microscopic disease or gross residual disease are eligible.
* Stage II, III or IV disease. Patients with disease outside the abdominal cavity are eligible unless presentation includes brain metastases.
* Able and willing to undergo a second look staging laparotomy.
* Patients must give written informed consent.
* Patient must be ag· Performance status (ECOG) \>2.
* Previous chemotherapy.
* Creatinine \> 1.5
* History of recent MI or congestive heart failure within 6 months of surgery
* SGOT \> 2x ULN, bilirubin \> 1.5 X ULN
* Concurrent invasive malignancy. (Patients with concurrent superficial endometrial carcinoma are eligible if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium).
* Known hypersensitivity to E.coli derived products?
* Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely e 18 years or older.
* Adequate bone marrow function with an ANC \> 2,500 and Platelets \>100,000/mm3.
Exclusion Criteria
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00157560
Study Brief:
Protocol Section:
NCT00157560