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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT00471432
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumors that have been shown to overexpress clusterin, including but not limited to, any of the following:
* Prostate cancer
* Renal cell carcinoma
* Non-small cell lung cancer
* Bladder cancer
* Breast cancer
* Ovarian cancer
* Metastatic or locally recurrent disease
* Refractory to standard curative therapy or no standard curative therapy exists
* Patients with prostate cancer must be hormone refractory (i.e., have documented evidence of progression while receiving androgen ablative therapy)
* Measurable or nonmeasurable disease
* Measurable disease defined as measurable lesion ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan or ≥ 10 mm by spiral CT scan
* No documented CNS metastases
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin normal
* Creatinine ≤ 2 times upper limit of normal (ULN)
* AST and ALT ≤ 1.5 times ULN
* PT/INR and PTT normal
* No uncontrolled pain
* No known bleeding disorder
* No history of serious allergic reaction to taxane (paclitaxel or docetaxel)
* No preexisting peripheral neuropathy ≥ grade 2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other serious illness or medical conditions that would preclude study compliance, including any of the following:
* Active uncontrolled infection
* Significant cardiac dysfunction
* No significant neurological disorder that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
* No prior strontium chloride Sr 89
* No more than 2 prior chemotherapy regimens, including adjuvant or neoadjuvant chemotherapy (for patients assigned to schedule B \[docetaxel once every 3 weeks\])
* More than 4 weeks since prior chemotherapy and recovered
* At least 4 weeks since prior antiandrogens
* More than 4 weeks since prior external-beam radiotherapy, except low-dose nonmyelosuppressive radiotherapy
* No prior radiotherapy to ≥ 30% of marrow-bearing areas (for patients assigned to schedule B \[docetaxel once every 3 weeks\])
* At least 28 days since prior new anticancer therapy
* At least 28 days since prior and no other concurrent investigational agents
* No concurrent radiotherapy, except low-dose nonmyelosuppressive radiotherapy
* No other concurrent cytotoxic therapy
* Concurrent luteinizing hormone-releasing hormone agonist allowed (if already initiated in patients with prostate cancer)
* No concurrent anticoagulant therapy (i.e., heparin, warfarin)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00471432
Study Brief:
Protocol Section:
NCT00471432