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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT00407758
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
* Recurrent or persistent disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Must have ≥ 1 target lesion to assess response
* Tumors within a previously irradiated field are designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy
* Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
* Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment
* Must meet any 1 of the following criteria for platinum-based therapy:
* Disease progression during therapy
* Treatment-free interval after completion of treatment \< 12 months
* Disease persistence after completion of therapy
* Ineligible for a higher priority GOG clinical trial
PATIENT CHARACTERISTICS:
* GOG performance status 0-1 (for patients who received 2 prior treatment regimens) OR 0-2 (for patients who received 1 prior treatment regimen)
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL (transfusions allowed)
* Creatinine \< 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2 times ULN
* Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)
* AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* Able to swallow tablets
* No sensory or motor neuropathy \> grade 1
* No active infection requiring antibiotics
* No other invasive malignancies or evidence of cancer within the past 5 years except nonmelanoma skin cancer
* No serious systemic disorders that would preclude study compliance, including an abnormal ECG indicative of cardiac disease
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior surgery, radiotherapy, or chemotherapy
* At least 1 week since prior anticancer hormonal therapy
* No more than 1 additional cytotoxic regimen for management of recurrent or persistent disease
* At least 4 weeks since other prior anticancer therapy, including immunotherapy
* At least 30 days since prior investigational drugs
* No prior enzastaurin hydrochloride
* No prior radiotherapy to \> 25% of marrow-bearing areas
* No prior noncytotoxic therapy, including bevacizumab, for recurrent or persistent disease
* No prior treatment that would preclude treatment on this protocol
* No concurrent chemotherapy, immunotherapy, or other experimental medications
* No concurrent enzyme-inducing antiepileptic drugs, including carbamazepine, phenobarbital, or phenytoin
* No other concurrent systemic anticancer therapy
* No concurrent radiotherapy, including palliative radiotherapy
* No concurrent agents that stimulate thrombopoiesis
* No concurrent amifostine or other protective reagents
* Concurrent hormone replacement therapy allowed
* Concurrent bisphosphonates allowed provided bony metastases are present
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00407758
Study Brief:
Protocol Section:
NCT00407758