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 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT00087035
Eligibility Criteria:
Inclusion Criteria
* Histologically confirmed adenocarcinoma of the prostate.
* Disease progression following primary or secondary hormonal therapy.
* All patients must be maintained on GnRH analog during this study.
* Serum PSA must be \> 20 ng/mL in patients without bidimensionally measurable disease or bone disease.
* Age \> 65 years.
* Karnofsky performance status of \> 70%.
* Life Expectancy of \> 12 weeks.
* Peripheral neuropathy, if present must be \< grade 1 by NCI criteria.
* Radionuclide bone scan and chest /abdominal/pelvic CT scan must be obtained in all patients within 4 weeks prior to cycle 1/day 1.
* Sexually active men must be willing to consent to using effective contraception while on treatment and for 6 months following treatment.
* No concomitant use of prostata or saw palmetto.
* Testosterone must be castrate levels(\< 50 ng/ml).
* WBC \> 2.8 x 109/L
* Granulocytes \> 1.5 x 109/L
* Platelets \> 100 x 109/L
* Hemoglobin \> 8.0 g/dL
* Serum creatinine \< 2.1
* Total bilirubin \< ULN
* Alkaline Phosphatase \< 2.5 ULN AND ALT/AST \< 2.0 ULN OR Alkaline Phosphatase 2.6-3.9 ULN, AND ALT/AST \<1.5 ULN OR Patients with known bone involvement may be included with alkaline phosphatase \> 4.0 ULN, IF ALT and AST and total bilirubin are within the normal range and the bone involvement is thought to account for elevated alkaline phosphatase.
* PT, INR should be within physiologic limits, i.e. INR 0.7 - 1.5. If patient is receiving anticoagulation therapy then INR should be within the range of 2.0 - 3.5.
Exclusion Criteria
* Any major surgery or radiotherapy, within 4 weeks prior to cycle 1/day 1 (within 12 weeks for previous treatment with strontium-89, rhenium, or sumarium).
* Hormonal therapy, with the exception of androgen deprivation therapy and stable regimens of prednisone and dexamethasone, (no change within 2 weeks prior to cycle1/day 1). Prior prostate hormonal treatment must have been discontinued at least four weeks (6 weeks for Casodex) prior to cycle1/day 1.
* Cardiovascular: Uncontrolled hypertension (resting blood pressure \>160/100 mm/Hg); clinical episodes of congestive heart failure, angina pectoris, or myocardial infarction within the last year.
* Any active infections (requiring IV antibiotics).
* Any prior chemotherapy.
* Not reliable for adequate follow-up.
* History of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
* Brain metastases or (clinical signs of) brain involvement or leptomeningeal disease.
* Patients with a history of another malignancy during the last 5 years other than prostate cancer, nonmelanomatous skin cancer or in situ bladder cancer (Stage T1a).
* Concurrent commercial or investigational antineoplastic therapy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
65 Years
Study:
NCT00087035
Study Brief:
Protocol Section:
NCT00087035