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Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer
This study is not yet open for participant recruitment.
Verified by Central European Cooperative Oncology Group, May 2007
Sponsored by: Central European Cooperative Oncology Group
Information provided by: Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00479752
  Purpose

To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.


Condition Intervention Phase
Colorectal Cancer
Drug: FOLFOX4 (Oxaliplatin), Cetuximab
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Oxaliplatin Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 + Weekly Cetuximab Versus FOLFOX4+ Biweekly Cetuximab as First-Line Therapy in Patients With Metastatic Colorectal Cancer.

Further study details as provided by Central European Cooperative Oncology Group:

Primary Outcome Measures:
  • objective response rate

Secondary Outcome Measures:
  • progression-free survival overall survival Safety

Estimated Enrollment: 150
Study Start Date: June 2007
Detailed Description:

This multicenter randomized phase II study will enroll approximately 150 patients with metastatic Colorectal Cancer. Patients are randomized in Arm A(FOLFOX4 in combination with weekly Cetuximab) or Arm B (FOLFOX4 in combination with biweekly Cetuximab). Both efficacy and safety data will be collected. The investigator will assess response to treatment every 8 weeks based on the imaging.

Following permanent treatment cessation, patients will be followed-up for survival.

  Eligibility

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

Inclusion Criteria:

  • Signed written informed consent
  • Male or female ≥ 18 years of age
  • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  • Metastatic colorectal carcinoma not suitable for curative-intent resection- Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
  • Presence of at least one lesion measurable unidimensionally by CT scan or MRI. (Target lesion(s) must not lie within an irradiated area)
  • Karnofsky performance status of > 80 at study entry
  • Leucocytes ≥ 3.0 x 10 9/L and neutrophils ≥1.5 x 10 9/L, platelets ≥ 100 x 10 9/L, and hemoglobin ≥ 9 g/dL.
  • Bilirubin ≥ 1.5 x ULN
  • ASAT and ALAT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis are present)
  • Serum creatinine ≤ 1.5 x ULN

Exclusion Criteria:

  • Brain metastasis (known or suspected)
  • Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed if the chemotherapy treatment free interval is > 6 months.
  • Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
  • Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
  • Any investigational agent(s) within 4 weeks prior to entry
  • Previous exposure to EGFR-pathway targeting therapy
  • Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
  • Acute or subacute intestinal occlusion or history of inflammatory bowel disease
  • Pre-existing neuropathy > grade 1. In case of prior oxaliplatin containing adjuvant chemotherapy: pre-existing neuropathy ≥ 1.
  • Known grade 3 or 4 allergic reaction to any of the components of the treatment.
  • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)
  • Pregnancy or lactation
  • Inadequate contraception (male or female patients) if of childbearing or procreational potential
  • Known drug abuse/ alcohol abuse
  • Legal incapacity or limited legal capacity
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479752

Contacts
Contact: Barbara Planko, Mag(FH) 43 1 4097725 barbara.planko@cecog.at

Locations
Austria, Steiermark
LKH Leoben, Abt. für Innere Medizin
Leoben, Steiermark, Austria, 8700
Bosnia and Herzegovina
Institute of Oncology Sarajevo
Sarajevo, Bosnia and Herzegovina
Bulgaria
SBALO National Oncology Center
Sofia, Bulgaria, 1754
Croatia
Clinical Hospital Split, Center of Oncology
Split, Croatia
University Hospital for Tumors
Zagreb, Croatia
University Hospital Rebro
Zagreb, Croatia
University Hospital Centre Rijeka
Rijeka, Croatia, 51000
Cyprus
Bank of Cyprus Oncology Center
Nikosia, Cyprus
Estonia
Noth estonian Regional Oncology Hospital
Tallin, Estonia, 13419
Hungary
Markusovsy Hospital
Szomathely, Hungary, 39700
National Medical Center
Budapest, Hungary, 1135
Semmelweis Univ. Radiology Clinic
Budapest, Hungary, 1082
Israel
Oncology Division Sourasky Medical Center
Tel Aviv, Israel, 64239
Meir Medical Center
Kfar Saba, Israel
Latvia
latvian Center of Oncology
Riga, Latvia, 1079
P. Stradins University Hospital
Riga, Latvia, 1020
Romania
Institutul Oncologic Bucuresti
Bucuresti, Romania
Serbia and Montenegro
Institute of Oncology and Radiology of Serbia
Belgrade, Serbia and Montenegro, 11000
Institute of Oncology of Vojvodina
Sremska Kamenica, Serbia and Montenegro, 21204
Slovakia
National Cancer Institute
Bratislava, Slovakia, 83310
National Institute of Oncology
Bratislava, Slovakia
Slovenia
Institute of Oncology
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Central European Cooperative Oncology Group
Investigators
Principal Investigator: Tudor Ciuleanu, Prof. Dr. Institutul Oncologic of Cluj
  More Information

Study ID Numbers: CECOG /CORE 1.2.002
Study First Received: May 25, 2007
Last Updated: May 25, 2007
ClinicalTrials.gov Identifier: NCT00479752  
Health Authority: Austria: Federal Ministry for Health and Women

Study placed in the following topic categories:
Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Cetuximab
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009