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Study Coordinator(s): David I. Quinn, M.D., Ph.D, Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Mark G. Garzotto, M.D., Carol M. Moinpour, Ph.D., Philip C. Mack, Ph.D., Karen M. Baranowski, N.P. Participants: Members, CCOP, UCOP, Affiliates, Medical Oncologists, Surgeons, CTSU Institutions in the United States Eligibility Criteria: Pts must have histologic dx of prostate adeno;any T, any N, M1b and evidence of bone mets on bone scan. Pts must have metastatic PCa deemed unresponsive or refractory to hormone tx by one or more of the criteria in Section 5.2. Pts must have prestudy PSA, CT or MRI of abd/pelvis, bone scan, Hg and alk phos w/in 28 days prior to reg. Pts must have completed baseline QOL forms w/in 14 days prior to registration. Pts must be offered participation in specimen banking (including the serum and tissue correlative studies and CTC measures). Pts must have been surgically or medically castrated and if medically, should be willing to continue/restart LHRH agonists. Tx w/non-steroidal antiandrogens (flutamide, bicalutamide, nilutamide or ketoconazole) must have stopped > 14 days prior to reg for ketoconazole and >28 days for flutamide, bicalutamide or nilutamide and pts must have demonstrated progression. Prior RT to less than 30% of bone marrow at least 21 days prior to reg allowed. Prior use of samarium allowed, but not strontium. Pts may have rec'd prior surgery at least 21 days prior to reg. One prior systemic therapy (vaccine or biologic) at least 28 days prior to reg allowed. Prior cytotoxic chemo for met PCa not allowed, but prior adjuvant therapy w/a single non-taxane containing cytotoxic regimen is permitted provided at least 2 yrs have elapsed since completion. Pts are permitted to take bisphosphonates provided they began bisphosphonate therapy prior to reg, they fulfill criteria for disease progression and they continue them per manufacturer guidelines or institutional practice. Pts not taking ongoing bisphosphonates will not be able to start them until they have completed 12 weeks of study treatment. Pts must be able to take oral meds. Pts must d/c herbal meds and food supplements prior to reg but may continue daily vitamins and calcium supplements. Pts must have HGB, alk phos and testosterone obtained w/in 28 days prior to reg. Pts must not have >/= Gr 2 Symptomatic Neuropathy Sensory. Pts must not have hx of hypersensitivity reaction to drugs formulated w/polysorbate 80. Pts must not take CYP3A4 inhibiting/inducing drugs listed in 5.18 w/in 14 days (6 months for amiodarone) prior to 1st dose of docetaxel through d/c of docetaxel. Pts must have Zubrod PS 0-3 and for those pts w/PS of 3, it must be due to pain 2ndary to bone mets. No other chemo, BRMs, RT, corticosteroid or hormonal concomitant therapy (other than LHRH or bisphosphonate usage) may be planned during protocol tx. Prior or concomitant use of megestrol acetate for hot flashes allowed. Pts rec'g finasteride, dutasteride or other 5 alpha reductase inhibitors are eligible provided it's clearly documented for BPH and they d/c them prior to registration. Pts w/hx of brain mets or who currently have brain mets are not eligible. Pts w/clinical evidence of brain mets must have a brain CT or MRI negative for met disease w/in 56 days prior to reg. Pts with 3rd space fluid accumulation such as ascites or symptomatic PE are not eligible. Pts must have recovered from any major infections and/or surgical procedures and not have significant active concurrent medical illness precluding protocol tx or survival. No other prior malignancy allowed except as in 5.24.
CANCER CONTROL CREDIT: 0.5
TREATMENT CREDIT: 1.0
CANCER CONTROL CREDIT: 0.5
TREATMENT CREDIT: 1.0
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