Phase II Study of XELOX and Cetuximab as First Line Therapy in Patients with Wild Type KRAS Metastatic Colorectal Cancer

Phase 2

• Conditions: Metastatic colorectal cancer

• Registration Number: JPRN-UMIN000007195
• Lead Sponsor: Epidemiological and Clinical research Information Network (ECRIN)

Brief Summary

ESULTS: Forty patients who fulfilled the inclusion criteria participated in this study. The median treatment cycle number was 8 and the median dose intensities were 218 mg/m2/wk for cetuximab, 34 mg/m2/wk for oxaliplatin, and 821 mg/m2/d for capecitabine. One patient showed complete response and partial response was observed in 19 patients, giving an overall RR of 50% (95% confidence interval [CI], 33.8%-66.2%). Stable disease was obtained in 13 patients, resulting in a DCR of 82.5% (95% CI, 67.2%-92.7%). The PFS was 6.5 months (95% CI, 3.5-9.6 months), and the OS was 24.3 months (95% CI, 14.9-33.7 months). The safety profile revealed the common Grade 3/4 adverse events to be acneiform eruption (12.5%), peripheral neuropathy (7.5%), and elevated alanine transaminase levels (7.5%). Grade 3/4 thrombocytopenia and neutropenia occurred only in 5.0% and 2.5% of the patients, respectively. Grade 1 hand-foot syndrome (HFS) was not uncommon (20%), whereas Grade 2/3 HFS occurred in only 3 patients (7.5%). No deaths were reported within 30 days of the last dose.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Severe myelosupression (2) Severe infectious disease (3) Sensory neuropathy (4) Psychological illness, Central nervous system damage or vascular brain disease (5) Comorbidity or history of heart failure (6) Intestinal lung disease or pulmonary fibrosis (7) Prior radiotherapy for metastatic mesurable lesions (8) History of severe allergy (9) Pregnancy and breast feeding (10) Severe comorbidity(renal failure, hepatic failure, hypertension, hypercalcemia) (11) Symptomatic brain metastases (12) multiple malignancy (13) Any other cases who are regarded as inadequate for study enrollment by investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response Rate

Secondary Outcome Measures

Name	Time	Method
Overall Survival, Progression Free Survival, Safety, Disease Control Rate, Dose Intensity, Surgery rate