Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer
This open-label, single-arm, multicenter, Phase 2 trial will treat at least 40 participants with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction (GEJ) who have not previously received systemic chemotherapy for this setting.
All eligible participants will receive the combination of cetuximab plus S-1 (a combination of tegafur, gimeracil, and oteracil) and cisplatin.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label, Single-arm, Multicenter Phase II Trial Investigating Cetuximab in Combination With S-1 and Cisplatin as First-line Treatment for Patients With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction|
- Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments [ Time Frame: Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012) ] [ Designated as safety issue: No ]The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 [RECIST v 1.0] criteria).
- Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments [ Time Frame: Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012) ] [ Designated as safety issue: No ]The PFS time is defined as the duration from start of treatment until radiological progression (based on RECIST v 1.0 criteria) or death due to any cause within 60 days of the last tumor assessment or start of treatment. Participants without event are censored on the date of last tumor assessment.
|Study Start Date:||June 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: Cetuximab plus cisplatin plus S-1||
Single first dose of cetuximab 400 milligram per square meter (mg/m^2) will be administered intravenously followed by once weekly subsequent intravenous infusion of cetuximab 250 mg/m^2 in each 5-week treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.Drug: Cisplatin
Cisplatin 60 mg/m^2 will administered as intravenous infusion on Day 8 of each 5-week cycle maximum up to 8 cycles until disease progression, unacceptable toxicity, or withdrawal of consentDrug: S-1
S-1, a combination of tegafur, gimeracil, and oteracil will be administered intravenously at a dose of 40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.