Bi-weekly Cetuximab Combined With FOLFOX-6 in Metastatic Colorectal Cancer - CEBIFOX

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by Universität Duisburg-Essen
Sponsor:
Information provided by:
Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01051167
First received: January 15, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bi-weekly Cetuximab Combined With FOLFOX-6 as First-line Treatment in Metastatic Colorectal Cancer Patients With Wild-type K-ras Status

Resource links provided by NLM:


Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Response rate (RECIST-Criteria) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objectives: Safety, Quality of life [ Time Frame: Every 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 59
Study Start Date: February 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab + Folfox-6-regime

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
500 mg /m² cetuximab as an intravenous infusion over 120 minutes on day 1 every 2 weeks
Other Name: Erbitux®

Detailed Description:

For years the effective treatment of advanced CRC was limited to 5-FU. Combination of 5-FU or a 5-FU analog with oxaliplatin, which has some antitumor activity as a single agent, shows synergistic activity. Combining oxaliplatin with a twice monthly folinic acid/5-FU schedule leads to a further improvement in first-line treatment of advanced CRC thus emerging to a standard regimen in first-line therapy of mCRC.

Cetuximab is normally given as a weekly schedule. As recently shown a biweekly schedule with 500 mg/m² instead of the weekly standard regimen (initial dose of 400 mg/m² followed by 250 mg/m² every week) exhibits similar pharmacokinetic results with a comparable efficacy.

In order to improve the convenience for the patients, this study will evaluate the efficacy and safety of a bi-weekly combination of cetuximab with FOLFOX. Out of the various FOLFOX regimens the most convenient FOLFOX-6 schedule is chosen for the study, which has been tested before in two studies in combination with the standard weekly schedule of cetuximab. Recent data suggest a decreased efficacy of cetuximab in patients bearing a k-ras mutation in their CRC. Therefore only patients with no evidence for a mutated k-ras gene in the colorectal carcinoma cells will be included in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 1st 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)
  • 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)

  • ASAT and 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

Exclusion Criteria:

  • 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-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
  • Participation in another clinical study within the 30 days before registration
  • Peripheral neuropathy > grade 1
  • Significant disease which, in the investigator's opinion, would exclude the patient from the study
  • Legal incapacity or limited legal capacity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051167

Contacts
Contact: Tanja Trarbach, MD +49(0)2 01 / 7233449 tanja.trarbach@uk-essen.de

Locations
Germany
University of Duisburg-Essen Medical School Recruiting
Essen, Nordrhein-Westfalen, Germany, 45122
Contact: Tanja Trarbach, MD    +49(0)201 / 7233449    tanja.trarbach@uk-essen.de   
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Tanja Trarbach, MD University of Duisburg-Essen Medical School
  More Information

No publications provided

Responsible Party: Tanja Trarbach, MD, University of Duisburg-Essen, Medical School
ClinicalTrials.gov Identifier: NCT01051167     History of Changes
Other Study ID Numbers: TT1-2007, 2007-000460-24
Study First Received: January 15, 2010
Last Updated: January 15, 2010
Health Authority: Germany:Paul-Ehrlich-Institute

Additional relevant MeSH terms:
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014