SWOG clinical trial number
S0421

Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer

Closed
Phase
Accrual
99%
Published
Abbreviated Title
Advanced Prostate
Activated
08/21/2006
Closed
05/01/2010
Participants
NCORP, Members, UCOP, Medical Oncologists, Surgeons, CTSU Institutions in the United States, Affiliates

Research committees

Genitourinary Cancer

Treatment

Prednisone Docetaxel Atrasentan Placebo

Eligibility Criteria Expand/Collapse

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

Publication Information Expand/Collapse

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

Bone turnover biomarkers identify unique prognostic risk groups in men with castration resistant prostate cancer and skeletal metastases: results from SWOG S0421

PN Lara;M Plets;C Tangen;E Gertz;N Vogelzang;M Hussain;P Twardowski;M Garzotto;JP Monk;M Carducci;A Goldkorn;PC Mack;DI Quinn;IM Thompson;M Van Loan Cancer Treatment and Research Communications

Inclusion of Patient-Reported Outcomes in Metastatic Castration-Resistant Prostate Cancer Clinical Trials: SWOG S0421 PRO Results and Methodological Issues

J Unger;K Griffin;GW Donaldson;K Baranowski;M Good;P Twardowski;P Van Veldhuizen;M Hussain;C Higano;PN Lara;C Tangen;DI Quinn;JL Wade;N Vogelzang;IM Thompson;C Moinpour Journal of Patient-Reported Outcomes

PMid: PMID29951640 | PMC number: PMC5997724

The association between ASCO Value framework and scientific and clinical impact of SWOG phase III clinical trials

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

2017

Validation of the association of RECIST changes with survival in men with metastatic castration resistant prostate cancer treated on SWOG study S0421

G Sonpavde;G Pond;M Plets;C Tangen;M Hussain;P Lara;A Goldkorn;M Garzotto;P Mack;C Higano;N Vogelzang;I Thompson;P Twardowski;P Van Veldhuizen;N Agarwal;M Carducci;JP Monk;DI Quinn Clinical Genitourinary Cancer Dec;15(6):635-641; 2017 May 10 [Epub ahead of print]

PMid: PMID28579151 | PMC number: PMC5734863

2016

Comorbidities and Risk of Chemotherapy-Induced Peripheral Neuropathy Among Participants 65 Years or Older in Southwest Oncology Group Clinical Trials

D Hershman;C Till;J Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology Sep 1;34(25):3014-3022; 2016 Jun 20 [Epub ahead of print]

PMid: PMID27325863 | PMC number: PMC5012713

A meta-analysis evaluating the impact of site of metastasis on overall survival in men with castration-resistant prostate cancer

S Halabi;W Kelly;H Ma;H Zhou;N Solomon;K Fizazi;C Tangen;M Rosenthal;D Petrylak;M Hussain;N Vogelzang;IM Thompson;KN Chi;J de Bono;A Armstrong;M Eisenberger;A Fandi;S Li;JC Araujo;C Logothetis;D Quinn;M Morris;C Higano;I Tannock;E Small Journal of Clinical Oncology May 10;34(14):1652-1659

PMid: PMID26951312 | PMC number: PMC4872320

Validation of the association of RECIST 1.0 changes with survival in men with metastatic castration resistant prostate cancer (mCRPC) treated on SWOG study S0421

G Pond;G Sonpavde;M Plets;C Tangen;M Hussain;P Lara;A Goldkorn;M Garzotto;C Higano;N Vogelzang;IM Thompson;P Twardowski;P Van Veldhuizen;N Agarwal;M Carducci;JP Monk;DI Quinn Journal of Clinical Oncology 34, 2016 (suppl; abstr 5079) American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), poster session

Comorbidities and risk of chemotherapy induced peripheral neuropathy among participants in SWOG clinical trials

DL Hershman;C Till;JD Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology 34, 2016 (suppl; abstr 10001); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), oral presentation

Bone biomarkers and overall survival (OS) in men with castration resistant prostate cancer (CRPC) and skeletal metastases: updated results from SWOG 0421, a phase III trial of docetaxel +/- atrasentan

PN Lara;M Plets;C Tangen;E Gertz;N Vogelzang;D Quinn;I Thompson;M van Loan Annals of Oncology vol. 27, 2016 Supp 6, abst. 754P; European Society for Medical Oncology (October 7-11, 2016, Copenhagen, Denmark), poster

2015

Circulating tumor cell telomerase activity as a prognostic marker for overall survival in metastatic castration resistant prostate cancer: results from SWOG S0421

A Goldkorn;B Ely;C Tangen;Y-C Tai;T Xu;H Li;P Twardowski;P Van Veldhuizen;N Agarwal;M Carducci;JP Monk;M Garzotto;P Mack;P Lara;C Higano;M Hussain;N Vogelzang;IM Thompson;R Cote;D Quinn International Journal of Cancer Apr 15;136(8):1856-1862

PMid: PMID25219358 | PMC number: PMC4323674

SWOG 0421: Impact of circulating markers of bone metabolism on overall survival in men with metastatic castration resistant prostate cancer (CRPC)

PN Lara;M Plets;C Tangen;E Gertz;DI Quinn;I Thompson;M Van Loan European Multidisciplinary Meeting on Urological Cancers (EMUC)(Nov 12-15, 2015, Barcelona, Spain), oral presentation; abst O6

2014

Serum biomarkers of bone metabolism in castration resistant prostate cancer patients with skeletal metastases

P Lara;B Ely;D Quinn;PC Mack;C Tangen;E Gertz;P Twardowski;A Goldkorn;M Hussain;N Vogelzang;IM Thompson;MD Van Loan Journal of the National Cancer Institute 106(4):dju013;

PMid: PMID24565955 | PMC number: PMC3982883

Circulating tumor cell (CTC) counts are prognostic of overall survival in SWOG S0421: docetaxel with or without atrasentan for metastatic castration resistant prostate cancer

A Goldkorn;B Ely;D Quinn;C Tangen;L Fink;T Xu;P Twardowski;P Van Veldhuizen;N Agarwal;M Carducci;JP Monk;RH Datar;M Garzotto;PC Mack;PN Lara;CS Higano;M Hussain;I Thompson;R Cote;N Vogelzang Journal of Clinical Oncology 32(11):1136-1142;

PMid: PMID24616308 | PMC number: PMC3970171

The site of visceral metastases (mets) to predict overall survival (OS) in castration-resistant prostate cancer (CRPC) patients (pts): A meta-analysis of five phase III trials

S Halabi;WK Kelly;H Zhou;AJ Armstrong;D Quinn;K Fizazi;NC Solomon;I Tannock;D Petrylak;MJ Morris;E Small Journal of Clinical Oncology 32:5s (suppl; abstr 5002); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), oral session;

2013

Docetaxel and atrasentan compared to docetaxel and placebo for men with advanced castration resistant prostate cancer: SWOG S0421

D Quinn;C Tangen;M Hussain;P Lara;A Goldkorn;M Garzotto;P Mack;M Carducci;JP Monk;P Twardowski;P Van Veldhuizen;N Agarwal;CS Higano;N Vogelzang;IM Thompson Lancet Oncology 14(9):893-900;

PMid: PMID23871417 | PMC number: PMC4277263

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;

Circulating tumor cell (CTC) counts and CTC telomerase activity (TA) are prognostic of overall survival (OS) in SWOG S0421 - docetaxel with or without atrasentan for metastatic castration resistant prostate cancer (mCRPC)

A Goldkorn;N Vogelzang;B Ely;LM Fink;DI Quinn;C Tangen;Y-C Tai;P Twardowski;PJ Van Veldhuizen;N Agarwal;MA Carducci;JP Monk;M Garzotto;P Mack;P Lara;C Higano;C Higano;R Cote;IM Thompson Journal of Clinical Oncology 30:(suppl 30; abstr 1); ASCO Markers in Cancer Annual Mtg, accepted, oral (Oct 11-13, 2012 Hollywood, FL);

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;

Other Clinical Trials

SWOG Clinical Trial Number
SWOG-7303
SWOG Clinical Trial Number
SWOG-8221 (INT-0007)

Treatment of Advanced Bladder Cancer with Preoperative Irradiation and Radical Cystectomy versus Radical Cystectomy Alone

Research Committee(s)
Genitourinary Cancer
Activated
10/29/1982
Closed
11/15/1989
Accrual
81%
Closed
Published
SWOG Clinical Trial Number
SWOG-8216/38

Comparison of BCG Immunotherapy and Adriamycin for Superficial Bladder Cancer

Research Committee(s)
Genitourinary Cancer
Activated
12/01/1982
Closed
01/15/1987
Closed
Phase
III
Published