SWOG clinical trial number
S0003

Randomized Phase III Trial of Carboplatin and Paclitaxel plus Tirapazamine versus Carboplatin and Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer - Cisplatin, Paclitaxel, Tirapazamine vs. Cisplatin, Paclitaxel - Specimen submission per S9925

Closed
Phase
Accrual
72%
Published
Abbreviated Title
Carbo/Pac + Tirapazamine vs. Carbo/Pac in Adv. NSCLC; Selected IIIB & IV
Activated
11/15/2000
Closed
11/15/2002
Participants
NCORP, Members, Medical Oncologists, Pathologists, EPP, CTSU

Research committees

Lung Cancer

Treatment

Paclitaxel Carboplatin Tirapazamine

Eligibility Criteria Expand/Collapse

Pts must have hist. or cyto. proven newly diagnosed selected Stage IIIB (T4 lesion due to malignant pleural effusion) or Stage IV, adv. primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous cell carcinoma or unspecified) or recurr. dz after previous surgery and/or RT; pts. must not have known brain mets; pts. must have measurable or non-measurable dz; pts. must have adequate renal, hematologic, hepatic and pulmonary function as outlined in Section 5.0; pts. must not have received any prior systemic chemo or biologic therapy for non-small cell lung cancer; prior RT > three weeks from reg is permitted; meas. or non-meas. dz must be outside the previous radiation field or a new lesion must be present.

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

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

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

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

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

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

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

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

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

2013

Chemotherapy outcomes by histological subtypes of non-small cell lung cancer: analysis of the SWOG database for antimicrotubule-platinum therapy

K Kelly;K Chansky;P Mack;P Lara;FR Hirsch;WA Franklin;A Wozniak;MJ Edelman;SK Williamson;DR Gandara Clinical Lung Cancer 14(6):627-635;

PMid: PMID23910067 | PMC number: PMC4122504

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

2009

Japan-USA common arm analysis of paclitaxel-carboplatin in advanced non-small cell lung cancer: a model for assessing population-related pharmacogenomics [PMC2717760; PMID19470925]

DR Gandara;T Kawaguchi;J Crowley;J Moon;K Feruse;M Kawahara;S Teramukai;Y Ohe;K Hubota;SK Willliamson;O Gautschi;HJ Lenz;HL McLeod;PN Lara;CA Coltman;M Fukuoka;N Saijo;M Fukushima;PC Mack Journal of Clinical Oncology 27(21)3540-3546

Chemotherapy outcomes by histologic subtype of non-small cell lung cancer (NSCLC): analysis of the SWOG database for antimicrotubule-platinum therapy

K Chansky;PC Mack;J Crowley;PN Lara;FR Hirsch;WA Franklin;DR Gandara Journal of Thoracic Oncology 4(9);suppl 1, abst. #B2.7, S326;

2008

Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials [PMID18202421]

PN Lara Jr;MW Redman;K Kelly;MJ Edelman;SK Williamson;JJ Crowley;DR Gandara Journal of Clinical Oncology 26(3):463-467

Lower osteopontin plasma levels are associated with superior outcomes following platinum-based chemotherapy in advanced non-small cell lung cancer patients: Southwest Oncology Group Trial S0003 [PMC2653139; PMID18779603]

PC Mack;M Redman;K Chansky;SK Williamson;NC Farneth;PN Lara;WA Franklin;QT Le;J Crowley;DR Gandara Journal of Clinical Oncology 26(29):4771-4775

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

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

Cooperative group research efforts in lung cancer 2008: focus on advanced-stage non-small-cell lung cancer

H Wakelee;K Kernstine;E Vokes;J Schiller;P Baas;N Saijo;A Adjei;G Gross;L Gaspar;D Gandara;H Choy;JB Putnam Clinical Lung Cancer 9(6):345-351

PMid: PMID19073517 | PMC number: (Reviews are not within the scope of the Public Access)

2007

Pharmacogenomic (PG) analysis of Japan-SWOG common arm study in advanced stage non-small cell lung cancer (NSCLC): a model for testing population-related pharmacogenomics

DR Gandara;T Kawaguchi;J Crowley;J Moon;M Kawahara;S Taramukai;S Williamson;K Furuse;HL McLeod;PC Mack Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#7500

Toxicity and survival by sex in patients with advanced non small cell lung carcinoma (NSCLC) on modern Southwest Oncology Group (SWOG) trials.

KS Albain;JM Unger;CC Gotay;AM Davies;M Edelman;RS Herbst;K Kelly;SK Williamson;AJ Wozniak;DR Gandara Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#7549

2006

Alternative measures predicting clinical benefit in advanced non-small cell lung cancer (NSCLC) from Southwest Oncology Group (SWOG) randomized trials: implications for clincial trial design

PN Lara;MW Redman;K Kelly;MJ Edelman;SK Williamson;JJ Crowley;DR Gandara Proc of the ASCO, Journal of Clinical Oncology 24(18S):#7006

Elevated osteopontin (OPN) plasma levels are highly prognostic in advanced non-small cell lung cancer (NSCLC): Analysis of SWOG S0003

PC Mack;MW Redman;K Chansky;SK Williamson;N Farneth;PN Lara;Q Le;PH Gumerlock;JJ Crowley;DR Gandara Proc of the ASCO, Journal of Clinical Oncology 24(18S):#7198

Second Japan-SWOG common arm analysis of paclitaxel/carboplatin in advanced stage non-small cell lung cancer (NSCLC): a model for testing population-related pharmacogenomics

J Crowley;K Furuse;M Kawahara;M Fukishima;S Williamson;PN Lara;P Mack;D Gandara Journal of Clinical Oncology 24(18S):#7050 (ASCO meeting proceedings - poster discussion)

2005

Phase III trial of paclitaxel plus carboplatin with or without tirapazamine in advanced non-small-cell lung cancer: Southwest Oncology Group trial S0003

SK Williamson;JJ Crowley;PN Lara Jr;J McCoy;DHM Lau;RW Tucker;GM Mills;DR Gandara Journal of Clinical Oncology 23(36):9097-9104

Plasma markers of tumor hypoxia-angiogenesis as predictors of therapeutic response

P Mack;PH Gumerlock;PN Lara;QT Le;JA Longmate;K Chansky;J Crowley;D Gandara Proc Amer Assoc Cancer Res, Vol. 46, abstr #1140

2004

Japan-SWOG common arm analysis of paclitaxel/carboplatin in advanced stage non-small cell lung cancer (NSCLC): a model for prospective comparison of cooperative group trials

DR Gandara;Y Ohe;K Kubota;Y Nishiwaki;Y Ariyoshi;N Saijo;S Williamson;PN Lara;J Crowley;M Fukuoka Proc of the American Society of Clinical Oncology 23:616 (#7007)

Hypoxia-related markers in the plasma of patients with advanced non-small cell lung cancer (NSCLC) and survival from chemotherapy: Southwest Oncology Group (SWOG) S0003

IV Galvin;PN Lara;Q Le;K Chansky;JJ Crowley;S Williamson;DR Gandara;PH Gumerlock Proc of the American Society of Clinical Oncology 23:649 (#7146)

Mutant DNA in plasma of lung cancer patients; potential for monitoring response to therapy

T Kimura;WS Holland;T Kawaguchi;SK Williamson;K Chansky;JJ Crowley;JH Doroshow;HJ Lenz;DR Gandara;PH Gumerlock Annals of the New York Academy of Sciences 1022:55-60

2003

S0003: Paclitaxel/carboplatin (PC) v PC + tirapazamine (PCT) in advanced non-small cell lung cancer (NSCLC). A phase III Southwest Oncology Group (SWOG) trial.

SK Williamson;JJ Crowley;PN Lara;RW Tucker;J McCoy;DHM Lau;DR Gandara Proc of the American Society of Clinical Oncology 22:622(#2502)

Hypoxia-induced proteins in plasma of patients on the Southwest Oncology Group (SWOG) S0003 trial in advanced non-small cell lung carcinoma (NSCLC)

IV Galvin;PN Lara;Q Le;K Chansky;J McCoy;JJ Crowley;DR Gandara;PH Gumerlock Proc of the American Society of Clinical Oncology 22:667(#2682)

S0003: paclitaxel/carboplatin (PC) versus PC + tirapazamine (PCT) in advanced non-small cell lung cancer (NSCLC). a phase III Southwest Oncology Group (SWOG) trial

SK Williamson;JJ Crowley;PN Lara;R Tucker;J McCoy;D Lau;DR Gandara Lung Cancer 41 (Suppl 2):S29 (#O-89)

Other Clinical Trials

SWOG Clinical Trial Number
S2414

INcorporating pathologic reSponse in patIents with early staGe lung cancer to optimize immunotHerapy in the adjuvanT setting (INSIGHT)

Research Committee(s)
Lung Cancer
Symptom Control and Quality of Life
Activated
03/14/2025
Accrual
1%
Open
Phase
SWOG Clinical Trial Number
CTSU/NRG-LU007