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 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT00030706
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma
* Recurrent or refractory disease
* Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel
* Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
* Bidimensionally measurable disease by physical exam, CT scan, or MRI
* Ascites and pleural effusions are not measurable disease
* No prior irradiation to indicator lesions
PATIENT CHARACTERISTICS:
Age
* 18 to 75
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
* No prior bleeding disorder or unexplained bleeding
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT/SGPT 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
* No active infection requiring antibiotics
* No grade 2 or greater neuropathy (sensory and motor)
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel
* No other medical condition that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
* No prior ixabepilone
* No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma
Endocrine therapy
* At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma
* Concurrent hormonal replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to a site of measurable disease used on study
* No prior radiotherapy to more than 25% of bone marrow
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Other
* At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma
* No prior cancer treatment for other invasive malignancies that would preclude study participation
* No concurrent heparin or other anticoagulants
* No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00030706
Study Brief:
Protocol Section:
NCT00030706