SWOG clinical trial number
S0124

Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer

Closed
Phase
Accrual
99%
Published
Abbreviated Title
Cis/Irinotecan vs. Cis/VP-16 in Extensive SCLC
Activated
11/01/2002
Closed
03/01/2007
Participants
NCORP, Members, Medical Oncologists, Pathologists, CTSU, Affiliates

Research committees

Lung Cancer

Treatment

Cisplatin Etoposide Irinotecan

Eligibility Criteria Expand/Collapse

Pts must have histologic/cytologic confirmation of extensive SCLC; Serum creatinine </= IULN or CrCl (calculated by Cockroft-Gault formula or measured by 24-hour urine collection) >/= 50 cc/min; bilirubin </= 1.5 x IULN; SGOT/SGPT </= 2.5 x IULN; PS 0-1; >/= WBC >/= 3, 000; AGC >/= 1,500; PLTS </= 100, 000; LDH obtained; Pts must be 21 days from surgery or brain RT and recovered from all toxicities; Pts with brain mets are eligible if brain mets are controlled; Pts must not have had prior malignancy except for adequately treated basal cell or squamous cell skin ca, in situ cervical ca, adequately treated Stage II or II ca from which the pt is currently in complete remission, or other cancer from which the pt has been disease-free for at least 5 yrs; Pts must not have concomitant active infection including HIV positivity or AIDS-related illness; Pts must not have had prior treatment for SCLC (except brain RT allowed); Pts must not be taking enzyme inducing anti-epileptic drugs (except phenytoin, phenobarbitol, oxcarbazepine and carbamazepine); Pts must not be pregnant or nursing and must agree to use an effective contraceptive method; institutions must have IRB approval of S9925 and pts must be offered participation in S9925 for study-associated blood draw.

This study has been approved by NCI's Central Institutional Review Board.

Publication Information Expand/Collapse

2018

Value of Anti-Cancer Drugs in SWOG Phase III Clinical Trials: Evidence from Multiple Evaluation Mechanisms

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster #B-335

2017

History of diabetes and outcome among participants 65 or older in SWOG clinical trials

DL Hershman;C Till;JD Wright;S Ramsey;W Barlow;J Unger JCO Clinical Cancer Informatics Nov;1:1-12; DOI: https://doi.org/10.1200/CCI.17.00040 Publishedonlineonascopubs.org/journal/ccion November 20, 2017.

PMid: PMID30657402 | PMC number: PMC6640843

2015

Multitrial evaluation of progression-free survival as a surrogate end point for overall survival in first-line extensive-stage small-cell lung cancer

NR Foster;LA Renfro;SE Schild;M Redman;XY Wang;S Dahlberg;K Ding;PA Bradbury;SS Ramalingam,;DR Gandara;T Shibata;N Saijo;E Vokes;A Adjei;SJ Mandrekar Journal of Thoracic Oncology Jul;10(7):1099-1106

PMid: PMID26134227 | PMC number: PMC4493926

2014

Comparison of survival outcomes among cancer patients treated in and out of clinical trials

J Unger;W Barlow;DP Martin;S Ramsey;M Leblanc;R Etzioni;D Hershman Journal of the National Cancer Institute 106(3):dju002; 2014 Mar 13 [Epub ahead of print];

PMid: PMID24627276 | PMC number: PMC3982777

The effect of the UGT1A1*28 allele on survival after irinotecan-based chemotherapy: a collaborative meta-analysis

MM Dias;J-P Pignon;CS Karapetis;V Boige;B Glimelius;DM Kweekel;PN Lara;Laurent-Puig;E Martinez-Balibrea;D Paez;CJA Punt;M Redman;G Toffoli;M Wadelius;RA McKinnon;MJ Sorich Pharmacogenomics Journal 214(5):424-431;

PMid: PMID24709690 | PMC number: pending

2013

Modeling the relationship between progression-free survival and overall survival: the phase 2/3 trial

M Redman;B Goldman;M LeBlanc;A Schott;LH Baker Clinical Cancer Research, 19(10):2646-2656;

PMid: PMID23669424 | PMC number: PMC4131693

2012

Efficacy and toxicity differences in lung cancer populations in the era of clinical trials globaliztion: the "common arm" approach

PC Mack;DR Gandara;PN Lara, Jr Expert Review of Anticancer Therapy 12(12):1591-1596

PMid: PMID23253224 | PMC number: Reviews are not within the scope of the Public Access Policy

2010

Common arm comparative outcomes analysis of phase 3 trials of cisplatin + irinotecan versus cisplatin + etoposide in extensive stage small cell lung cancer: final patient-level results from Japan Clinical Oncology Group 9511 and Southwest Oncology Group 0124 [PMID20737417; PMC2994945]

P Lara;K Chansky;T Shibata;H Fukuda;T Tamura;J Crowley;M Redman;R Natale;N Saijo;D Gandara Cancer 116(24):5710-5715

2009

Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124 [PMID19349543; PMC2684855]

PN Lara;RB Natale;JJ Crowley;HJ Lenz;M Redman;JE Carleton;J Jett;CJ Langer;JP Kuebler;SR Dakhil;K Chansky;DR Gandara Journal of Clinical Oncology 27(15):2530-2535

Cisplatin (Cis) + irinotecan (CPT11) vs. Cis + etoposide (VP16) in extensive stage small cell lung cancer (E-SCLC): final comparative outcomes analysis of JCOG 9511 and SWOG 0124

PN Lara;K Chansky;T Shibata;H Fukuda;T Tamura;N Saijo;HJ Lenz;RB Natale;JJ Crowley;DR Gandara Journal of Clinical Oncology 27:15s, abst. #8027

Final pooled comparative outcomes analysis of JCOG 9511 and SWOG 0124, phase III trials of cisplatin + irinotecan vs. cisplatin + etoposide in extensive stage small cell lung cancer

PN Lara;K Chansky;T Shibata;H Fukuda;T Tamura;J Saijo;HJ Lenz;R Natale;J Crowley;M Redman;DR Gandara Journal of Thoracic Oncology 4(9):suppl 1, abst. D5.7, S396, 2009 (IASLC 13th World Conf on Lung Cancer, oral pres);

Cooperative group research endeavors in small-cell lung cancer: current and future directions [PMID19808190]

R Sangha;P Lara;AA Adjei;P Baas;H Choy;L Gaspar;G Goss;N Saijo;JH Schiller;EE Vokes;D Gandara Clinical Lung Cancer 10(5):322-330

PMC number: n/a (review)

2008

S0124: A randomized phase III trial of cisplatin + irinotecan (PI) versus cisplatin + etoposide (PE) in 671 patients (pts) with extensive stage small cell lung cancer (E-SCLC)

RB Natale;PN Lara;K Chansky;J. Crowley;JR Jett;JE Carleton;JP Kuebler;H Lenz;P Mack;DR Gandara Journal of Clinical Oncology 26(15S):400s, #7512

Progress in small cell lung cancer: the lowest common denominator [PMID18779609]

DR Gandara;PN Lara, Jr.;RB Natale;C Belani Journal of Clinical Oncology 26(26):4236-4238

2007

Cisplatin (Cis)/etoposide (VP16) compared to cis/irinotecan (CPT11) in extensive-stage small cell lung cancer (E-SCLC): pharmacogenomic (PG) and comparative toxicity analysis of JCOG 9511 and SWOG 0124

P Lara Jr;M Redman;H Lenz;M Gordon;T Shibata;H Fukuda;T Tamura;N Saijo;R Natale;DR Gandara Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#7524