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:
NCT00416533
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate with any of the following:
* Prostate-specific antigen ≥ 10 mg/dL
* Bone disease
* Bidimensional soft tissue disease
* Evaluable disease
* Advanced disease AND failed prior primary androgen ablation therapy, including anti-androgen withdrawal
* Disease not amenable to local curative treatment
* No known brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine \< 2.0 mg/dL
* SGPT and SGOT \< 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ ULN
* Hemoglobin ≥ 10 g/dL
* Ejection fraction ≥ 50%
* Peripheral neuropathy ≤ grade 1
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No previous history of or concurrent malignancy, except for any of the following:
* Inactive nonmelanoma skin cancer
* Disease-free for five or more years
* Adequately treated stage I or II cancer from which patient is currently in complete remission
* No other serious medical illness that would limit survival to less than 3 months
* No psychiatric condition that would prevent informed consent
* No active, uncontrolled bacterial, viral, or fungal infection
* No hemorrhagic disorder
* No history of severe hypersensitivity reaction to other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No new hormonal treatment within the past 4 weeks
* No prior immunotherapy, chemotherapy, or bone-seeking radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
* Prior bisphosphonates allowed
* At least 2 weeks since prior radiotherapy
* No other concurrent chemotherapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00416533
Study Brief:
Protocol Section:
NCT00416533