NCT00422773

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

February 27, 2009

Status Verified

February 1, 2009

Enrollment Period

1.4 years

First QC Date

January 15, 2007

Last Update Submit

February 26, 2009

Conditions

Metastatic Colorectal Cancer

Keywords

phase I/IIcetuximaboxaliplatinirinotecan5-FUchemotherapydose escalationsafety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

Study Arms (1)

Cetuximab+ FOLFOXIRI

EXPERIMENTAL

Cetuximab and Irinotecan, Oxaliplatin, 5FU and Folinic acid

Drug: Cetuximab

Interventions

CetuximabDRUG

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

Also known as: Cetuximab (C225, Erbitux by Merck)
Cetuximab+ FOLFOXIRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik

Dresden, Saxony, 01307, Germany

Location

Westdeutsches Tumorzentrum, Universitaetsklinikum Essen

Essen, 45112, Germany

Location

Universitaetsklinik Mannheim GmbH, III. Medizinische Klinik

Mannheim, 68167, Germany

Location

Related Publications (1)

  • Folprecht G, Hamann S, Schutte K, Trarbach T, Stoehlmacher-Williams J, Ehninger G. Dose escalating study of cetuximab and 5-FU/folinic acid (FA)/oxaliplatin/irinotecan (FOLFOXIRI) in first line therapy of patients with metastatic colorectal cancer. BMC Cancer. 2014 Jul 19;14:521. doi: 10.1186/1471-2407-14-521.

    PMID: 25038824DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gunnar Folprecht, Dr.

    University Hospital Dresden, Medical Department I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2007

First Posted

January 17, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2008

Last Updated

February 27, 2009

Record last verified: 2009-02

Locations

DE(3)