NCT01718808

Cetuximab for Elderly Patients With mCRC

Cetuximab Monotherapy and Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With KRAS- and BRAF Wild-type Metastatic Colorectal Cancer. A Multicenter Phase II Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVE: The objective of the trial is to judge on the benefit obtained by an upfront cetuximab treatment delivered as monotherapy or as part of a combination treatment with capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type and B-type Raf kinase (BRAF) wild-type metastatic colorectal cancer (mCRC).

Detailed description

Primary endpoint: If in a treatment arm the number of patients alive and without progression at 12 weeks is 17 or more, this arm will be considered promising, otherwise not promising. Additionally, a two-sided 95% confidence interval for the difference in Progression free survival (PFS) rates between the two arms will be calculated. Secondary endpoints and patient characteristics: * Laboratory values may be expressed as the absolute values (continuous variables) or/and as grading (ordinal categorical variables). * Generally for each categorical variable the results will be summarized by frequencies and percentages. For response rates 95% Clopper-Pearson confidence intervals will be calculated. * For each adverse event, the results will be summarized by frequencies and percentages of different grades among all cycles as well as by frequencies and percentages of the within-patient worst grades * For each continuous variable the results will be summarized by descriptive statistics. * Time-to-event variables will be presented by Kaplan-Meier curves and summarized by medians and 95% confidence intervals. * All analysis will be done by treatment arm.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab	Cetuximab 500 mg/m2 every second week (days 1, 15, 29, etc.) until progression or unacceptable toxicity
DRUG	Capecitabine	Capecitabine 1000 mg/m2 bid p.o. (750 mg/m2 if creatinine clearance 30-50 ml/min according to Cockroft-Gault formula, on days 1-14 every 3 weeks, restart on day 22

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-12-01
• Completion: 2017-01-01
• First posted: 2012-10-31
• Last updated: 2017-01-24

Locations

14 sites across 1 country: Switzerland