Safety and Efficacy Study of Combination Therapy With Cetuximab and FOLFOX4 in Patients With Colorectal Cancer

NCT00202787 | Completed Phase 2

• 2 other identifiers: TTD-04-02eudract-number: 2004-001700-12
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab and FOLFOX4 or FOLFOX4 alone in patients with CRC and non-resectable hepatic metastases

Conditions

Colorectal Cancer

Keywords

colorectal cancer; cetuximab; FOLFOX4

Outcome Measures

Primary Outcomes (1)

• Determine confirmed objective response rate

  2005-2009

Secondary Outcomes (2)

• Determine safety of combination, surgical resectability and R0 resections, clinical benefit, time to disease progression, time to onset of response, duration of response, time to treatment failure, overall survival time

  2005-2009

• determination of polymorphisms of the intron 1 of the EGFR gene, TS, XRCC1, XPD, serum levels of EGFR and ATP7A and ATP7B, nº of copies of EGFR gene, the levels of PTEN, EGFR, AKT y MAPK proteins, and mutations at EGFR, PI3KCA, K-RAS y B-RAF genes

  2005-2009

Study Arms (2)

1

EXPERIMENTAL

FOLFOX-4+cetuximab

Drug: FOLFOX-4+cetuximab

2

ACTIVE COMPARATOR

FOLFOX-4

Drug: FOLFOX-4

Interventions

FOLFOX-4+cetuximab DRUG

Cetuximab; Weekly administration of Cetuximab IV (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes); FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2

1

FOLFOX-4 DRUG

FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Men and women \< 75 years
• Histologically confirmed diagnosis of CRC
• Metastatic colorectal carcinoma with exclusive non-resectable hepatic metastases, due to fulfillment of one of the following criteria:
• Number of hepatic metastases \> or= 4;
• Size of one or more hepatic metastases \> 5 cm diameter;
• Vascular involvement and/or poor site that prevent complete resection of hepatic disease and/or require resection with the remaining liver mass less than 25-30% of functional liver.
• Presence of at least one lesion detectable by two-dimensional measurement.
• Karnofsky functional status \>or=70% at the time of enrollment in study
• Life expectancy greater than 3 months.
• Patients must not have received chemotherapy for advanced/metastatic disease.
• Patients with the following characteristics will be enrolled:
• Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free period \> 6 months following conclusion of treatment.
• Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment.
• De novo diagnosis of disease.

You may not qualify if:

• Documented or suspected cerebral and/or leptomeningeal metastases.
• Metastasis in any other non-hepatic site, including extrahepatic lymph node metastases.
• Surgery (excluding biopsy for diagnosis) and/or radiotherapy within 4 weeks prior to enrollment in the study.
• Participation in another clinical trial with medication in the past 30 days.
• Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone therapy or any other investigational drug.
• Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma.
• Any investigational drug during the 4 weeks prior to enrolment.
• Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
• Prior participation in study in which treatment with cetuximab can be assigned (whether or not treatment with cetuximab is received)
• Acute or subacute intestinal occlusion or history of inflammatory intestinal disease.
• Evidence of grade 3 or 4 allergic reaction to any of the treatment components.
• Clinically relevant peripheral neuropathy.
• Clinically relevant myocardial disease or history of myocardial infarction in the past 12 months.
• Known abuse of alcohol / drugs, Legal incapacity or limited legal capacity.
• Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent.

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Albert Abad

  Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

ES (1)