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
Abbreviated Title
PANCREATIC
Treatment
Gemcitabine hydrochloride
Cetuximab
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.
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
