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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00053833
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or pathologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
* No mixed mullerian and borderline ovarian tumors
* Surgically staged as stage III or IV at initial diagnosis
* Must meet one of the following criteria for refractory/relapsed disease:
* Relapsed within 6 months after completing front-line concurrent or sequential platinum (either cisplatin or carboplatin) and taxane (paclitaxel or docetaxel) chemotherapy
* Had a best response of increasing disease during this front-line regimen
* Consolidation chemotherapy and reinduction therapy are counted as part of the front-line regimen
* Unidimensionally measurable disease
* At least 2 cm by medical photograph (skin or oral lesion), palpation, plain x-ray, CT scan, MRI, or other conventional technique (bone lesions not included)
* At least 1 cm by spiral CT scan
* Measurable disease must remain outside of radiotherapy field
* If the tumor is known to be KIT (CD117) or PDGFR positive, patient must be offered SWOG-S0211 if available
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No myocardial infarction within the past 6 months
* No angina pectoris
* No uncontrolled congestive heart failure
* No uncontrolled cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except for the following:
* Adequately treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Adequately treated stage I or II cancer from which the patient is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No more than 1 prior biological response modifier
* At least 28 days since prior biological response modifier and recovered
Chemotherapy
* See Disease Characteristics
* No prior topotecan or other topoisomerase I inhibitor
* One other additional prior chemotherapy regimen allowed
* At least 28 days since prior chemotherapy (14 days for weekly chemotherapy) and recovered
Endocrine therapy
* Prior hormonal therapy allowed
* No concurrent hormonal therapy
Radiotherapy
* At least 28 days since prior radiotherapy and recovered
* No prior radiotherapy to more than 25% of bone marrow
* No concurrent palliative radiotherapy
Surgery
* At least 14 days since prior major surgery and recovered
Other
* At least 28 days since prior investigational drugs and recovered
* No other concurrent antitumor therapy
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00053833
Study Brief:
Protocol Section:
NCT00053833