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 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT00006028
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma
* Recurrent or persistent disease
* Bidimensionally measurable disease by physical examination or medical imaging techniques
* Sonography is acceptable if lesions are clearly defined on initial examination and bidimensionally measurable
* Ascites and pleural effusions are not considered measurable disease
* Must not be eligible for a higher priority Gynecologic Oncology Group protocol
* Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
* Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment
* If no prior paclitaxel, a second regimen containing paclitaxel allowed
* Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based therapy of less than 6 months or progressed during platinum-based therapy)
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* Sensory and motor neuropathy no greater than grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic or immunologic therapy for ovarian or peritoneal cancer
Chemotherapy:
* See Disease Characteristics
* No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
* No prior gemcitabine
* At least 3 weeks since prior chemotherapy for ovarian or peritoneal cancer and recovered
Endocrine therapy:
* At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer
* Concurrent continuation of hormonal replacement therapy allowed
Radiotherapy:
* At least 3 weeks since prior radiotherapy for ovarian or peritoneal cancer and recovered
* No prior radiotherapy to only site of measurable disease
* No prior radiotherapy to more than 25% of bone marrow
Surgery:
* See Disease Characteristics
* At least 3 weeks since prior surgery for ovarian or peritoneal cancer and recovered
Other:
* At least 3 weeks since other prior therapy for ovarian or peritoneal cancer
* No prior cancer treatment that would preclude study
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00006028
Study Brief:
Protocol Section:
NCT00006028