Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal Cancer

February 26, 2009 updated by: Technische Universität Dresden

Open Labeled, Multicenter Phase I/II Study Evaluating the Dose Escalation/Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan as First-Line Treatment of Metastatic Colorectal Cancer

The purpose of this study is to assess a maximal tolerable dose and to assess the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-fluorouracil (5-FU)/folinic acid (FA) as first-line treatment for metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dose escalation:

The first three patients will receive chemotherapy at the dose level 1 for 6 weeks (first three cycles). The dose will be escalated for the next patients by one dose level if none of the three patients at a dose level experience a dose-limiting toxicity (DLT) during the first six weeks. If one of the three patients has a DLT, an additional three patients will be enrolled at this dose level and the dose will be escalated if no additional patients experience a DLT. Otherwise, the dose escalation will be stopped, and the last dose will be regarded as the maximum tolerated dose (MTD). An intra-individual dose escalation is not planned.

Expanded cohort:

The MTD cohort will be expanded to a total of 16 patients.

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 2
  • Phase 1

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

  • Germany
      • Essen, Germany, 45112
        • Westdeutsches Tumorzentrum, Universitaetsklinikum Essen
      • Mannheim, Germany, 68167
        • Universitaetsklinik Mannheim GmbH, III. Medizinische Klinik
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of non-resectable, histologically confirmed, epithelial growth factor receptor(EGFR)-positive or negative colorectal cancer
  • WHO Performance status 0 or 1
  • Signed written informed consent
  • ≥ 18 years of age
  • Effective contraception for both male and female subjects if the risk of conception exists
  • Adequate bone marrow function: neutrophil blood cell count (NBC) ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 5.96 mmol/L (10 g/dL)
  • Adequate liver and renal function: bilirubin ≤ 1.5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks; ASAT and ALAT ≤ 5 x UNL; serum creatinine ≤ 1.5 x UNL.

Exclusion Criteria:

  • Previous exposure to epidermal growth factor receptor-targeting therapy
  • Previous chemotherapy for colorectal cancer except for adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment or 5-FU in combination with radiotherapy for rectal cancer
  • Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion.
  • Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy.
  • Investigational agents or participation in clinical trials within 30 days before start of the treatment in study.
  • Clinically relevant coronary disease or myocardial infarction within 12 months before study entry.
  • Peripheral neuropathy > CTC (Common Toxicity Criteria)grade I
  • Inflammatory bowel disease
  • Previous malignancy (except for colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
  • History of severe psychiatric illness
  • Drug or alcohol abuse
  • Known hypersensitivity reaction to any of the components of study treatment
  • Pregnancy (absence to be confirmed by b-hCG (pregnancy-) test) or lactation period
  • Brain metastasis and/or leptomeningeal disease (known or suspected)
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cetuximab+ FOLFOXIRI
Cetuximab and Irinotecan, Oxaliplatin, 5FU and Folinic acid
Drug: Cetuximab
Dose level Infusion time (h) Dose level unit 1 2 3 4 Cetuximab 2.0 mg/m² 500 500 500 500 Irinotecan, before oxaliplatin 1.0 mg/m² 95 125 165 180 Oxaliplatin, with folinic acid 2.0 mg/m² 85 85 85 85 Folinic acid, with folinic acid 2.0 mg/m² 400 400 400 400 5-FU Infusion 46.0 mg/m² 3200 3200 3200 3200
Other Names:
  • Cetuximab (C225, Erbitux by Merck)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess a maximal tolerable dose and the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-FU/folinic acid as first-line treatment for metastatic colorectal cancer

Secondary Outcome Measures

Outcome Measure
To assess the treatment regarding the following: feasibility, toxicity, response rate, resection rate, progression free and overall survival

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Gunnar Folprecht, Dr., University Hospital Dresden, Medical Department I

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

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

January 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 15, 2007

First Submitted That Met QC Criteria

January 15, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

February 27, 2009

Last Update Submitted That Met QC Criteria

February 26, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-COFI-014

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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