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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT00114166
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
* Recurrent disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* At least 1 target lesion not in a previously irradiated field
* Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound
* Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
* Patients who have not received prior paclitaxel may receive a second regimen that includes paclitaxel
* Platinum-sensitive disease
* Treatment-free interval\* without clinical evidence of progressive disease for \> 6 months after prior response to a platinum-based regimen NOTE: \*Non-platinum maintenance or consolidation therapy is not included in calculation of the treatment-free interval
* Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance \> 40 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No sensory or motor neuropathy \> grade 1
* No active infection requiring antibiotics
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 weeks since prior biologic or immunologic agents for the malignancy
* No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent disease
* No concurrent cytokines during the first course of study treatment
* No concurrent pegfilgrastim
Chemotherapy
* See Disease Characteristics
* See Biologic therapy
* Recovered from prior chemotherapy
* No other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen
* No prior topotecan
Endocrine therapy
* At least 1 week since prior hormonal therapy for the malignancy
* Concurrent hormone replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
* No prior radiotherapy to \> 25% of marrow-bearing areas
Surgery
* Recovered from prior surgery
Other
* At least 3 weeks since other prior therapy for the malignancy
* No prior anticancer therapy that would preclude study treatment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00114166
Study Brief:
Protocol Section:
NCT00114166