SWOG clinical trial number
S9916

Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer, Phase III.

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Advanced Prostate
Activated
10/15/1999
Closed
01/15/2003
Participants
NCORP, Members, UCOP, Medical Oncologists, Surgeons, NCCTG, CALGB, EPP, CTSU

Research committees

Genitourinary Cancer

Treatment

Prednisone Docetaxel Estramustine Mitoxantrone

Eligibility Criteria Expand/Collapse

Pts must have hist dx of adenocarcinoma of the prostate which is measurable or evaluable Stage D1 or D2. Pts must have metastatic PC deemed unresponsive or refractory to hormone therapy by one or more of the following: Progression of bidimensionally measurable disease assessed w/in 28 days of reg, progression of evaluable but not measurable disease assessed w/in 42 days of reg and/or rising PSA (2 consecutive). Prestudy PSA required for all pts w/in 28 days prior to reg. CT scan of abd/pelvis w/in 28 days prior to reg. Bone scan w/in 42 days prior to reg. Pt must have been surgically or medically castrated. If castration was by LHRH agonists, pt should be willing to continue or restart LHRH agonist. If pt has been treated w/non-steroidal antiandrogens, they must have been stopped (see protocol for timeframes) and pt must have progressed. Prior RT (to less than 30% of bone marrow) is allowed (at least 28 days must have elapsed); this includes samarium, but not strontium. Prior surgery is allowed provided pt has recovered from all side effects(at least 21 days must have elapsed). One prior systemic therapy is allowed (at least 28 days must have elapsed). Prior therapy must not have included estramustine, taxanes, anthracyclines, or mitoxantrone. Pts must have stopped bisphosphonates at least 28 days prior to reg and pt must not be planning to receive any concomitant bisphosphonates. Pts with hx of MI are not eligible. Must have EKG within 42 days of registration. LVEF by MUGA within 42 days prior to registration. Serum creatinine less than or equal to 2.0 mg/dl within 28 days prior to registration. PS 0-3. No other chemo, BRMs, RT, corticosteroid, or hormonal therapy may be planned during treatment. Prior or concomitant use of megace for tx of hot flashes is allowed. Pts with hx of brain mets or untreated brain mets are not eligible. Pts with active thrombophlebitis or hypercoagulability are not eligible. Pts w/known history of PE are not eligible. Pts receiving anticoagulation therapy (except aspirin) are not eligible. Pts are permitted to have prior coumadin for prophylaxis against agents that might produce blood clots. Pts w/third space fluid accumulation such as ascites or symptomatic pleural effusion are not eligible. All pts must be offered participation in the correlative tissue studies/banking outlined in Section 15.24. SWOG pts must be offered participation on SWOG-9205.

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

Key Design and Analysis Principles for Quality of Life and Patient Reported Outcomes in Clinical Trials

J Unger;R Vaidya;J Gore Urologic Oncology Mar 20 [Epub ahead of print]

PMid: PMID29572075 | PMC number: NIHMSID946008

Estimating global treatment toxicity burden from adverse-event data

SM Lee;DL Hershman;J Miao;X Zhong;J Unger;Y Cheung Cancer Feb 15;124(4):858-864. Epub 2017 Nov 7

PMid: PMID29112232 | PMC number: PMC5801103

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

2017

Association between body mass index and cancer survival in a pooled analysis of 22 clinical trials

H Greenlee;J Unger;M Leblanc;S Ramsey;D Hershman Cancer Epidemiology Biomarkers & Prevention 2017 Jan;26(1):21-29; 2016 Dec 16. [Epub ahead of print]

PMid: PMID27986655 | PMC number: PMC5370550

The effect of positive SWOG treatment trials on survival of patients with cancer in the US population

JM Unger;M Leblanc;CD Blanke JAMA Oncology Oct 1;3(10):1345-1351

PMid: PMID28586789; PMC5710507

The impact of positive SWOG treatment trials on population survival

J Unger;M LeBlanc;C Blanke J Clin Oncol 35, 2017 (suppl; abstr 6513); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), poster discussion

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

Identifying severe adverse event clusters using the National Cancer Institute's Common Terminology Criteria for Adverse Events

X Zhong;E Lim;DL Hershman;CM Moinpour;JM Unger;SM Lee Journal of Oncology Practice, Mar;12(3):245-246

PMid: PMID26907453 | PMC number: PMC5702793

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

2014

Enhancing nurse contributions to SWOG clinical trials

L Hansen;C Moinpour;R Ermete Seminars in Nursing Oncology 30(1):26-31;

PMid: PMID24559777 | PMC number: PMC3961058

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;

Association between BMI at treatment initiation and cancer survival across multiple SWOG trials

H Greenlee;J Unger;M Leblanc;D Hershman AACR Research International Conference on Frontiers on Cancer Research Prevention (Sept 28-Oct 1, 2014, New Orleans, LA; poster

2009

Chemotherapeutic impact on pain and global health-related quality of life in homone-refractory prostate cancer: dynamically modified outcomes analysis of a randomized controlled trial [PMC2859212; PMID19130298]

CM Moinpour;GW Donaldson;Y Nakamura Quality of Life Research 18:147-155

Prostate-specific antigen progression (PSA-P) predicts overall survival (OS) in patients with metastatic prostate cancer: data from Southwest Oncology Group (SWOG) trials 9346 (INT 0162) and 9916 [PMC2684851; PMID19380444]

M Hussain;B Goldman;C Tangen;CS Higano;DP Petrylak;G Wilding;A Akdas;EJ Small;BJ Donnelly;L Collette;PA Burch;RS DiPaola;ED Crawford Journal of Clinical Oncology 27(15):2450-2456

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;

2008

Prostate-specific antigen progression (PSA-P) predicts overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916.

B Goldman;M Hussain;C Tangen;C Higano;DP Petrylak;NJ Vogelzang;ED Crawford Journal of Clinical Oncology 26(15s):253s, #5015

Prostate specific antigen progression (PSA-P) as a predictor of overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916

B Goldman;M Hussain;C Tangen;C Higano;DP Petrylak;N Vogelzang;ED Crawford Proceedings of the American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, abst. 165

The Southwest Oncology Group: progress in cancer research [PMID18929152]

CA Coltman Seminars in Oncology 35(5):545-552

2007

Association of body mass index with response and survival in men with metastatic prostate cancer: Southwest Oncology Group trials 8894 and 9916 [PMID17868721]

RB Montgomery;B Goldman;CM Tangen;M Hussain;DP Petrylak;S Page;EA Klein;ED Crawford Journal of Urology 178(5):1946-1951

Do general dimensions of quality of life add clinical value to sympton data? [PMID17951229]

CM Moinpour;GW Donaldson;MW Redman Journal of the National Cancer Institute Monogr. 37:31-38

2006

Evaluation of prostate-specific antigen declines for surrogacy in patients treated on SWOG 99-16

D Petrylak;D Pauler Ankerst;CS Jiang;CM Tangen;MHA Hussain;PN Lara;JA Jones;ME Taplin;PA Burch;M Kohli;MC Benson;EJ Small;D Raghavan;ED Crawford Journal of the National Cancer Institute 98(8):516-521

Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel/estramustine to mitoxantrone/prednisone

DL Berry;CM Moinpour;CS Jiang;DP Ankerst;DP Petrylak;LV Vinson;PN Lara;S Jones;ME Taplin;PA Burch;MHA Hussain;ED Crawford Journal of Clinical Oncology 24(18):2828-2835

2004

Quality of Life (QOL) and pain in advanced stage prostate cancer: impact of missing data on evaluating palliation in SWOG 9916

DL Berry;CM Moinpour;C Jiang;LV Vinson;PN Lara;S Lanier;ME Taplin;PA Burch;DP Petrylak;ED Crawford Proc of the American Society of Clinical Oncology 23:400, (#4579)

Three-month change in PSA as a surrogate endpoint for mortality in advanced hormone-refractory prostate cancer (HRPC): data from Southwest Oncology Group Study S9916

ED Crawford;DK Pauler;CM Tangen;MHA Hussain;EJ Small;ME Taplin;PA Burch;GF Greene;PN Lara Jr;DP Petrylak Proc of the American Society of Clinical Oncology 23:382 (#4505)

SWOG 99-16: randomized phase III trial of docetaxel (D)/estramustine (E) versus mitoxantrone (M)/prednisone (p) in men with androgen-independent prostate cancer (AIPCA)

DP Petrylak;C Tangen;M Hussain;PN Lara;J Jones;M Talpin;P Burch;G Greene;E Small;ED Crawford Proc of the American Society of Clinical Oncology 23:2 (#3)

Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer

DP Petrylak;CM Tangen;MHA Hussain;PN Lara Jr;JA Jones;ME Taplin;PA Burch;D Berry;C Moinpour;M Kohli;MC Benson;EJ Small;D Raghavan;ED Crawford New England Journal of Medicine 351(15):1513-1520

2000

Behavioral science research in the cooperative group setting: the Southwest Oncology Group Experience

CC Gotay;CM Moinpour;S Moody-Thomas;ER Gritz;KS Albain;E DeAntoni;L Hansen;PA Ganz Journal of the National Cancer Institute 92(17):1381-1387

1999

Docetaxel (Taxotere) and estramustine versus mitoxantrone and prednisone for hormone-refractory prostate cancer: scientific basis and design of Southwest Oncology Group study 9916

M Hussain;D Petrylak;E Fisher;C Tangen;D Crawford Seminars in Oncology 26(5):55-60(Suppl.17)

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