Bi-weekly Cetuximab Combined With 5-fluorouracil/Leucovorin/Oxaliplatin (FOLFOX-6) in Metastatic Colorectal Cancer

NCT01051167 | Completed Phase 2

• 2 other identifiers: TT1-20072007-000460-24
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

Brief Summary

Cetuximab is normally given as a weekly schedule in the therapy of patients with metastatic colorectal cancer. In order to improve the convenience for the patients in first line-therapy this study will evaluate the efficacy and safety of a bi-weekly combination of cetuximab with FOLFOX.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate (RECIST-Criteria)

  Every 8 weeks

Secondary Outcomes (1)

• Secondary objectives: Safety, Quality of life

  Every 2 weeks

Study Arms (1)

Cetuximab + Folfox-6-regime

EXPERIMENTAL

Cetuximab 500 mg/m² administered as an intravenous infusion over 120 minutes on day 1 every 2 weeks. Combined with the following FOLFOX-6-regime: Oxaliplatin 85 mg/m² i.v. for 2 h on day 1, Folinic acid 400 mg/m² i.v. for 2 h concurrently with Oxaliplatin on day 1, Fluorouracil 400 mg/m² i.v. bolus after Folinic Acid on day 1, followed by Fluorouracil 2400 mg/m² i.v. over 46 h.

Drug: Cetuximab

Interventions

Cetuximab DRUG

500 mg /m² cetuximab as an intravenous infusion over 120 minutes on day 1 every 2 weeks

Also known as: Erbitux®

Cetuximab + Folfox-6-regime

Eligibility Criteria

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

You may qualify if:

• Histologically proven metastatic colorectal cancer
• Molecular test showing no mutation in the k-ras gene of colorectal carcinoma cells
• Male and female subjects ≥ 18 years of age
• st occurrence of metastatic disease (not curatively resectable)
• Life expectancy ≥ 12 weeks
• Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at study entry
• Adequate bone marrow reserve:
• leucocytes ≥ 3.0 x 109/l with neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, haemoglobin ≥ 6.21 mmol/l (10 g/dl)
• Aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT) ≤ 2.5 x upper reference range, in case of liver metastasis ≤ 5 x upper reference range
• Serum creatinine ≤ 1.5 x upper reference range
• Bilirubin ≤ 1.5 x upper reference range
• Negative pregnancy test for female and effective contraception for both male and female subjects if the risk of conception exists
• Signed written informed consent

You may not qualify if:

• Evidence for a mutation of the k-ras gene in the colorectal carcinoma cells
• Previous exposure to epidermal growth factor receptor-targeting therapy
• Prior chemotherapy for metastatic disease
• Prior oxaliplatin based adjuvant chemotherapy or \< 6 months after end of adjuvant treatment
• Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
• Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before registration
• Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol
• Creatinine clearance \< 30 ml/min
• Known hypersensitivity reaction to any of the components of study treatment
• Pregnancy (absence to be confirmed by ß-human chorionic gonadotropin (hCG) test) or lactation period
• Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
• Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
• Brain metastasis (known or suspected)
• Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
• Known alcohol or drug abuse

Sponsors & Collaborators

• Martin Schuler, Prof. Dr. med.: lead

Study Sites (3)

University of Duisburg-Essen Medical School

Essen, North Rhine-Westphalia, 45122, Germany

Location

Alfried Krupp von Bohlen und Halbach Krankenhaus gGmbH

Essen, North Rhine-Westphalia, 45131, Germany

Location

Prosper Hospital Recklinghausen

Recklinghausen, North Rhine-Westphalia, 45659, Germany

Location

Related Publications (1)

• Kasper S, Meiler J, Knipp H, Hohler T, Reimer P, Steinmetz T, Berger W, Linden G, Reis H, Markus P, Paul A, Dechene A, Schumacher B, Kostbade K, Virchow I, Ting S, Worm K, Schmid KW, Herold T, Wiesweg M, Schuler M, Trarbach T. Biweekly Cetuximab Plus FOLFOX6 as First-Line Therapy in Patients With RAS Wild-Type Metastatic Colorectal Cancer: The CEBIFOX Trial. Clin Colorectal Cancer. 2020 Dec;19(4):236-247.e6. doi: 10.1016/j.clcc.2020.03.003. Epub 2020 Mar 19.

  PMID: 32737003 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Martin Schuler, Prof.Dr.med.

  University of Duisburg-Essen Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: February 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)