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
III
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

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

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)