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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)

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ClinicalTrials.gov Identifier: NCT01161316
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: mFOLFOX-6 + cetuximab until disease progression or early withdrawal. Drug: 8 cycles of mFOLFOX-6 + cetuximab, followed by cetuximab alone until disease progression or early withdrawal. Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 2010-2014 ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2010-2014 ]
  2. rate of objective responses [ Time Frame: 2010-2014 ]
  3. disease's resectability (R0) [ Time Frame: 2010-2014 ]
  4. evaluate hypomagnesaemia as a predictive factor in the treatment's efficacy [ Time Frame: 2010-2014 ]
  5. Adverse events [ Time Frame: 2010-2014 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161316


Locations
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Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Investigators
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Study Chair: Enrique Aranda Hospital Reina Sofia. Córdoba. Spain
Study Chair: Eduardo Díaz-Rubio Hospital Clínico San Carlos. Madrid. Spain
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
ClinicalTrials.gov Identifier: NCT01161316    
Other Study ID Numbers: TTD-09-04
2009-017194-38 ( EudraCT Number )
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Keywords provided by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD):
metastatic colorectal cancer
wild-type KRAS tumours
cetuximab
mFOLFOX-6
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents