SWOG clinical trial number
S0421
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer
Abbreviated Title
Advanced Prostate
Treatment
Prednisone
Docetaxel
Atrasentan
Placebo
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.
CCOP Credit: 0.5 Cancer Control Credit
1.0 Treatment Credit
2012
SWOG 0421: Prognostic and predictive value of bone metabolism biomarkers (BMB) in castration resistant prostate cancer (CRPC) patients (pts) with skeletal metastases treated with docetaxel +/- atrasentan (ATR)
P Lara;B Ely;D Quinn;C Tangen;E Gertz;M Hussain;N Vogelzang;I Thompson;M Van Loan J Clin Oncol 30 (suppl; abstr 4547); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), poster discussion;
SWOG S0421: phase III study of docetaxel and placebo (P) for men with advanced castrate resistant prostate cancer
DI Quinn;C Tangen;M Hussain;P Lara;A Goldkorn;MG Garzotto;PC Mack;M Carducci;JP Monk;P Twardowski;P Van Veldhuizen;N Agarwal;CS Higano;N Vogelzang;IM Thompson J Clin Oncol 30 (suppl; abstr 4511); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), oral presentation;
Results of circulating tumor cell counts using the CellSearch platform in a prospective randomized phase III SWOG-sponsored prostate cancer trial (S0421)
N Vogelzang;B Ely;LM Fink;A Goldkorn;C Tangen;P Twardowski;P Van Veldhuizen;N Agarwal;M Carducci;JP Monk;M Garzotto;PC Mack;PN Lara;C Higano;M Hussain;D Quinn;RJ Cote;IM Thompson J Clin Oncol 30 (suppl; abstr 10503); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), oral presentation;
Results of telomerase activity measurements from live circulating tumor cells captured on a slot microfilter in a phase III SWOG-coordinated prostate cancer trial (S0421)
A Goldkorn;B Ely;DI Quinn;C Tangen;Y-C Tai;P Twardowski;P Van Veldhuizen;N Agarwal;M Carducci;JP Monk;MG Garzotto;PC Mack;PN Lara;CS Higano;M Hussain;N Vogelzang;RJ Cote;IM Thompson J Clin Oncol 30 (suppl; abstr 4663); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), poster presentation;
2010
Circulating tumor cell capture and analysis in a multi-center SWOG-coordinated prostate cancer trial
A Goldkorn;T Xu;B Lu;A Williams;LM Fink;C Tangen;YC Tai;DI Quinn;P Twardowski;RJ Cote Journal of Clinical Oncology 28:7s, 2010 (suppl;abstr TPS342); ASCO; poster
2009
Cooperative group trials - Southwest Oncology Group (SWOG) innovations in advanced prostate cancer [PMID21085622; PMC2981166]
TB Dorff;C Tangen;ED Crawford;DP Petrylak;CS Higano;D Raghavan;DI Quinn;NJ Vogelzang;IM Thompson;MHA Hussain Therapeutic Advances in Medical Oncology 1(2):69-77;
