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

Merck KGaA, Darmstadt, Germany344 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

344

Conditions

Neoplasm Metastasis Colorectal Cancer

Interventions

CetuximabBIOLOGICAL

Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops

OxaliplatinDRUG

Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (78)

Outcomes

Primary Outcomes

Best Overall Response Rate - Independent Review Committee (IRC)

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.

Time frame: 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

Secondary Outcomes

Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)

Time frame: 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

Best Overall Response Rate (KRAS Mutant Population)

Time frame: 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

Progression-free Survival Time

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.

Time frame: 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

Data from ClinicalTrials.gov

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Research Site

Graz, Austria

Research Site

Linz, Austria

Research Site

Salzburg, Austria

Research Site

Vienna, Austria

Research Site

Zams, Austria

Research Site

Antwerp, Belgium

Research Site

Bonheiden, Belgium

Research Site

Bruges, Belgium

Research Site

Hasselt, Belgium

Research Site

Leuven, Belgium

...and 68 more locations

Progression-free Survival Time (KRAS Wild-Type Population)

Time frame: 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

Progression-free Survival Time (KRAS Mutant Population)

Time frame: 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

Overall Survival Time

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.

Time frame: 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

Overall Survival Time (KRAS Wild-Type Population)

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.

Time frame: 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

Overall Survival Time (KRAS Mutant Population)

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.

Time frame: 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

Participants With No Residual Tumor After Metastatic Surgery

No residual tumor after on-study surgery for metastases.

Time frame: 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

Disease Control Rate (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).

Time frame: 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

Duration of Response

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.

Time frame: 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

Safety - Number of Patients Experiencing Any Adverse Event

Please refer to Adverse Events section for further details

Time frame: 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