SWOG clinical trial number
S0205

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer

Closed
Phase
Accrual
100%
Published
Abbreviated Title
PANCREATIC
Activated
01/01/2004
Closed
04/01/2006
Participants
NCORP, Members, Medical Oncologists, CTSU

Research committees

Gastrointestinal Cancer

Treatment

Gemcitabine hydrochloride Cetuximab

Eligibility Criteria Expand/Collapse

Histologic or cytologic diagnosis of pancreatic adenocarcinoma. No endocrine tumors, lymphoma of the pancreas or ampullary cancer. Locally advanced dz that is not surgically resectable, or distant metastatic dz. No known brain metastases. Must submit tumor tissue for EGFR testing prior to registration. Measurable or non-measurable dz. Prior surgery allowed if 14 days have elapsed and recovered from all effects. No prior chemotherapy, hormonal therapy, immunotherapy or chemoradiotherapy for advanced pancreas cancer. Prior adjuvant chemotherapy allowed if at least 6 months have elapsed since completion. No prior gemcitabine. Prior radiation for palliation to metastatic sites allowed if at least 28 days have elapsed and recovered from all effects. No prior cetuximab or other therapy that targets the EGF pathway. No prior chimerized or murine monoclonal antibody therapy. Lab results within 14 days: AGC >= 1,500/µl; platelets >= 100,000/µl; bilirubin <= 2.0 x IULN; serum creatinine <= 2.0 mg/dl; SGOT or SGPT <= 2.5 x IULN. Zubrod 0-2. If able to read and understand English, must complete quality of life questionnaires. No significant history of cardiac disease. EKG within 3 months prior to registration. No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on protocol. No HIV-positive patients. No pregnant or nursing women. No other prior malignancy except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in remission or any other cancer from which the patient has been disease-free for 5 years.

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

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

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

Historical controls for metastatic pancreatic cancer: benchmarks for planning and analyzing single arm phase II trials

PA Philip;K Chansky;L Rubenstein;M Leblanc;L Seymour;SP Ivy;SR Alberts;PJ Catalano;J Crowley Clinical Cancer Research 20(16):4176-4185;

PMid: PMID24914040 | PMC number: PMC4296727

2012

Use of EGF A61G polymorphism predicts overall survival in a phase III study of gemcitabine plus cetuximab versus gemcitabine in patients (pts) with locally advanced or metastatic pancreatic adenocarcinoma (SWOG 0205)

J Labonte;B Goldman;Wu Zhang;M Labonte;C Blanke;P Philip;R Wong;E O'Reilly;J Benedetti;HJ Lenz Journal of Clinical Oncology 30(supl 4; abstr 203); ASCO 2012 GI Cancers Symposium, poster presentation;

2010

Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205. [PMID20606093; PMC2917315]

PA Philip;JK Benedetti;CL Corless;R Wong;E O'Reilly;PJ Flynn;KM Rowland;JN Atkins;BC Mirtsching;SE Rivkin;AA Khorana;B Goldman;CM Fenoglio-Preiser;JL Abbruzzese;CD Blanke Journal of Clinical Oncology 28(22):3605-3610;

Pain and emotional well-being outcomes in Southwest Oncology Group-directed intergroup trial S0205: a phase III randomized, open-label study comparing gemcitabine plus cetuximab (IMC-225) versus gemcitabine as first-line therapy of patients with advanced pancreas cancer [PMID20606094; PMC2917316]

CM Moinpour;N Vaught;B Goldman;M Redman;PA Philip;B Millwood;S Lippman;TE Seay;P Flynn;E O'Reilly;KM Rowland;R Wong;J Benedetti;CD Blanke Journal of Clinical Oncology 28(22):3611-3616

2008

Interim futility analysis with intermediate endpoints

B Goldman;M LeBlanc;J Crowley Clinical Trials 5(1):14-22

PMid: PMID18283075

2007

Phase III study of gemcitabine (G) plus cetuximab (C) versus gemcitabine in patients (pts) with locally advanced or metastatic pancreatic adenocarcinoma (PC): SWOG S0205 study

PA Philip;J Benedetti;C Fenoglio-Preiser;M Zalupski;H Lenz;E O'Reilly;R Wong;J Atkins;J Abbruzzese;C Blanke Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#LBA4509