Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)

Phase 2

Completed

• Conditions: Neoplasm Metastasis; Colorectal Cancer
• Interventions: Biological: Cetuximab; Drug: Oxaliplatin

• Registration Number: NCT00125034
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-28
• Study First Submitted QC: 2005-07-28
• Study First Posted: 2005-07-29
• Primary Completion: 2007-03
• Study Completion: 2010-11
• Status Verified: 2011-08
• Results First Submitted: 2011-08-23
• Results First Submitted QC: 2011-08-23
• Results First Posted: 2011-10-04
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

• First-line mCRC
• EGFR positive
• Bi-dimensional measurable index lesion

Exclusion Criteria

• Previous exposure to EGFR-targeting therapy
• Previous oxaliplatin-based therapy
• Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
• Radiotherapy
• Surgery
• Any other investigational drug in the 30 days before randomization
• Brain metastasis and/or leptomeningeal disease
• Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cetuximab Plus FOLFOX-4	Cetuximab	-
FOLFOX-4 Alone	Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
Best Overall Response Rate - Independent Review Committee (IRC)	Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006	The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.

Secondary Outcome Measures

Name	Time	Method
Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)	Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007	The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.
Best Overall Response Rate (KRAS Mutant Population)	Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007	The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.
Progression-free Survival Time	Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007	Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.; Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Progression-free Survival Time (KRAS Wild-Type Population)	Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008	Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.; Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Progression-free Survival Time (KRAS Mutant Population)	Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008	Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.; Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Overall Survival Time	Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008	Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Overall Survival Time (KRAS Wild-Type Population)	Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008	Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Overall Survival Time (KRAS Mutant Population)	Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008	Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Participants With No Residual Tumor After Metastatic Surgery	Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008	No residual tumor after on-study surgery for metastases.
Disease Control Rate (Cut Off Date 4 August 2006)	Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006	The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments as assessed by IRC (based on modified WHO criteria).
Duration of Response	Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007	Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).; Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
Safety - Number of Patients Experiencing Any Adverse Event	time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008	Please refer to Adverse Events section for further details

Trial Locations

Locations (1)

Research Site; 🇺🇦 Vinnitsa, Ukraine