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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT00005820
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate with clinically progressive stage IVA or IVB disease after at least primary androgen ablation with either orchiectomy or LHRH agonist and only one cytotoxic chemotherapy regimen
* Measurable disease with a maximum of 10 measurable lesions OR nonmeasurable disease
* Serum testosterone no greater than 50 ng/mL if no prior bilateral orchiectomy
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* ECOG 0 or 1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3 (transfusion independent)
* No disseminated intravascular coagulation
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 3 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* Fertile patients must use effective contraception
* No currently active second malignancy other than nonmelanoma skin cancers
* No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
Chemotherapy:
* See Disease Characteristics
* At least 6 weeks since prior suramin
* At least 4 weeks since other prior chemotherapy
* No prior therapy with camptothecin or any of its analogues
Endocrine therapy:
* Prior second line hormonal therapy allowed
* At least 4 weeks since prior hormonal therapy
* Concurrent treatment with LHRH agonists allowed and required for
* patients without orchiectomy
* No concurrent hormonal therapy except for nondisease related conditions
* Concurrent corticosteroids allowed if on stable dose for at least 6 weeks
* before study
* No concurrent dexamethasone as an antiemetic
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
* No palliative radiotherapy
* At least 8 weeks since prior strontium 89 or samarium 153
Surgery:
* At least 3 weeks since major surgery and recovered
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00005820
Study Brief:
Protocol Section:
NCT00005820