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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT00005857
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV prostate cancer (any T, any N, M1, any G; D3)
* Clinical evidence of metastatic disease in bone or soft tissue
* Her2/neu-positive (2+ and 3+) by immunochemistry or fluorescent in situ hybridization
* Androgen-independent
* Serum PSA at least 10 ng/mL that has risen on 3 successive evaluations after prior hormonal therapy
* At least 1 month since prior antiandrogen therapy (e.g., flutamide, bicalutamide, or nilutamide) and rising PSA levels with 1 of the 2 rising PSA levels, measured at least 2 weeks apart, after antiandrogen withdrawal
* Bone only disease and elevated PSA alone allowed
* LHRH analog therapy must continue in patients who have not had prior orchiectomy and have castrate levels of testosterone
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* SWOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 3,500/mm3
* Absolute granulocyte count at least 1,800/mm3
* Platelet count at least lower limit of normal (LLN)
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT no greater than 2 times ULN
Renal:
* Creatinine no greater than 1.6 mg/dL
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* Ejection fraction more than 50% or more than LLN by MUGA scan or 2-D echocardiogram
* No symptomatic coronary artery disease
* No active ischemia on EKG
Other:
* Fertile patients must use effective contraception
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent biologic therapy
Chemotherapy:
* No more than one prior nonanthracycline chemotherapy regimen (including suramin)
Endocrine therapy:
* See Disease Characteristics
* No concurrent corticosteroids as antiemetic
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* At least 3 months since prior strontium chloride Sr 89 and recovered
* No concurrent radiotherapy to measurable lesions
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00005857
Study Brief:
Protocol Section:
NCT00005857