Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Pati… (NCT00038194) | Clinical Trial Compass
CompletedPhase 1
Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer
United States28 participantsStarted 2001-10
Plain-language summary
The goal of this clinical research study is to find the highest safe dose of docetaxel in combination with Gleevec (imatinib mesylate) that can be given to men with advanced androgen-independent metastatic prostate cancer that involves bone. Docetaxel is a commercial chemotherapy which interferes with the cancer cell ability to divide and grow.
Who can participate
SexMALE
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Inclusion:
* Patients with histologic proof of adenocarcinoma of the prostate and must have progressed on conventional hormonal therapy.
* Patients must have bone metastases which can be demonstrated by bone scans. Lytic bone lesions should be considered for biopsy if there is a clinical suspicion of histologic conversion to small cell carcinoma.
* Patients must have evidence of progression of disease. PSA- progression is defined as 2 consecutive increments in PSA (an absolute change of at least 1ng/mL) over 4 weeks. An increase by 25% of the product of bidimensional disease qualifies as progression. An increase in the number of metastatic lesions on bone scan qualifies as progression.
* All patients must have a minimum PSA of 1ng/ml.
* Patients on antiandrogens should be discontinued from flutamide or nilutamide for at least 4 weeks and bicalutamide for 8 weeks. If progression is documented as below prior to this time interval, patients are eligible.
* Patients must have a performance status of \< 2 (ECOG).
* Patients must have an expected survival from cancer or co-morbidity of at least three months.
* Patients may receive no concurrent chemotherapy, immunotherapy or ketoconazole.
* Patients should not have received prior chemotherapy or radiation within the last 30 days and no Strontium or Samarium within the last 90 days.
* Patients must have castrate serum testosterone levels (\< 30ng/dl). For patients who are medically castrated, luteinizing hormone releasing hormone a…