Safety and Efficacy Study of mFOLFOX-6 Plus Cetuximab for 8 Cycles Followed by mFOLFOX-6 Plus Cetuximab or Single Agent Cetuximab as Maintenance Therapy in Patients With Metastatic Colorectal Cancer and WT KRAS Tumours (MACRO-2)

July 24, 2015 updated by: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Phase-II, Randomized, Multicentre Pilot Study to Evaluate the Safety and Efficacy of the Treatment With mFOLFOX-6 Plus Cetuximab Versus Initial Treatment With mFOLFOX-6 Plus Cetuximab (for 8 Cycles), Followed by Maintenance With Cetuximab Alone as First-line Treatment in Patients With Metastatic Colorectal Cancer (mCRC) and Wild-type KRAS Tumours

The purpose of the study is to evaluate the efficacy and safety of the combination of mFOLFOX-6 plus cetuximab for 8 cycles followed by mFOLFOX-6 plus cetuximab or single agent (s/a) cetuximab as maintenance therapy in patients (pts) with metastatic colorectal cancer (mCRC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent.
  • Patients of an age ≥ 18 years and < 71
  • Patients with an ECOG performance status ≤ 2
  • Confirmed histological diagnosis of colorectal carcinoma with metastatic disease and wild-type KRAS.
  • Presence of at least one target lesion that is measurable one-dimensionally (not located in an irradiated region).
  • Life expectancy greater than 12 weeks.
  • First evidence of chemotherapy-naïve metastatic disease. Adjuvant chemotherapy is allowed if it has been more than 6 months since the treatment was finished and there have been no signs of disease progression, neither during treatment nor during the 6 months following its completion.
  • Adequate medullar reserve:
  • Absolute neutrophil count ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Haemoglobin ≥ 9 g/dL
  • Adequate renal function: Creatinine clearance > 30 mL/min, calculated using the Cockroff-Gault formula, or a serum creatinine < 2 mg/dL or 177 umol/L
  • An adequate liver function: ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x ULN (≤ 5 x ULN if there are liver metastases). Total bilirubin < 1.5 x ULN. Alkaline phosphatase ≤ 2.5 x ULN ( ≤ 5 x ULN in the case of liver metastases or ≤ 10 x ULN in the case of bone metastases)

Exclusion Criteria:

  • To have received prior systemic treatment for the metastatic disease
  • Diagnosis or suspicion of brain or leptomeningeal metastases
  • Major surgery or radiotherapy (except for antalgic surgery that does not include measurable target lesions) during the 4 weeks prior to inclusion in the study.
  • Previous administration of monoclonal antibodies, agents inhibiting EGFR signal transduction or EGFR-targeted treatment.
  • Participation in another clinical trial with drugs within the previous 30 days.
  • Neoplasm in the 2 years prior to entering the study, except for non-melanoma skin carcinoma or in situ cervix carcinoma.
  • Evidence of previous acute hypersensitivity reaction of any degree to any of the treatment's components.
  • Clinically relevant peripheral neuropathy.
  • Signs and symptoms, at the moment of entering the study, of acute or subacute bowel obstruction.
  • A history of an acute episode of ischemic heart disease (angina or acute myocardial infarction) within the previous 12 months or an elevated risk of heart failure decompensation or uncontrolled arrhythmia.
  • Serious active infection, including active tuberculosis and HIV diagnosis.
  • Chronic immunological or hormonal treatment, except for hormone replacement treatment at physiological doses.
  • Known drug or alcohol abuse.
  • Legal incapacity or limited legal capacity.
  • Pregnancy or breastfeeding. Premenopausal women must have a negative pregnancy test in urine or blood before entering the trial. Patients and their partners must take contraceptive measures (hormonal, barrier, or abstinence) if the possibility of conception exists, during the study and for 3 months after the end of the treatment thereof.
  • Any geographical or social circumstance or any medical or psychological alteration that, in the investigator's opinion, will not allow the patient to conclude the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
mFOLFOX-6 + cetuximab until disease progression or early withdrawal.
Drug: mFOLFOX-6 + cetuximab until disease progression or early withdrawal.

Treatment regimen:

mFOLFOX-6, day 1, every two weeks; OXALIPLATIN 85 mg/m2; FOLINIC ACID 400 mg/m2; 5-FU 400 mg/m2 IV bolus; 5-FU 2400 mg/m2 continuous infusion for 46 hours

Cetuximab weekly. Cetuximab 400 mg/m2 the first time the treatment is administered; 250 mg/m2 for subsequent administrations.
EXPERIMENTAL: Experimental
8 cycles of mFOLFOX-6 + cetuximab, followed by cetuximab alone until disease progression or early withdrawal.
Drug: 8 cycles of mFOLFOX-6 + cetuximab, followed by cetuximab alone until disease progression or early withdrawal.

Treatment regimen.

mFOLFOX-6. day 1 every two weeks. OXALIPLATIN 85 mg/m2; FOLINIC ACID 400 mg/m2; 5-FU 400 mg/m2 IV bolus; 5-FU 2400 mg/m2 continuous infusion for 46 hours

Cetuximab weekly. Cetuximab 400 mg/m2 the first time the treatment is administered; 250 mg/m2 for subsequent administrations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 2010-2014
2010-2014

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 2010-2014
2010-2014
Adverse events
Time Frame: 2010-2014
2010-2014
rate of objective responses
Time Frame: 2010-2014
2010-2014
disease's resectability (R0)
Time Frame: 2010-2014
2010-2014
evaluate hypomagnesaemia as a predictive factor in the treatment's efficacy
Time Frame: 2010-2014
2010-2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Investigators

  • Study Chair: Enrique Aranda, Hospital Reina Sofia. Córdoba. Spain
  • Study Chair: Eduardo Díaz-Rubio, Hospital Clinico San Carlos. Madrid. Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

July 12, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (ESTIMATE)

July 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 24, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTD-09-04
  • 2009-017194-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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