Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer - Full Text View

Sponsored by:	Central European Cooperative Oncology Group
Information provided by:	Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00286130

Purpose

In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.

The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first

Condition	Intervention	Phase
Metastatic Colorectal Cancer	Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil 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 Randomised, Open-Label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + 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:

the percentage of patients surviving without disease progression in each arm at 9 months

Secondary Outcome Measures:

PFS rates at 3,6,12 months
Response rates
Overall survival (OS) in each arm
Safety

Enrollment:	150
Study Start Date:	July 2005
Estimated Study Completion Date:	October 2007

Detailed Description:

The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC.

EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively.

Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.

Eligibility

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

Criteria

Inclusion Criteria:

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 unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area)
ECOG performance status of < 2 at study entry

Exclusion Criteria:

Brain metastasis (known or suspected)
Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months
Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry
Cocurrent 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286130

Show 27 Study Locations

Sponsors and Collaborators

Central European Cooperative Oncology Group

Investigators

Principal Investigator:

Werner Scheithauer, MD

Dep. of Internal Medicine I, Medical University of Vienna

More Information

Study ID Numbers:	CECOG/Core 1.2.001, EUDRACT number 2004-002391-42
Study First Received:	February 2, 2006
Last Updated:	May 10, 2007
ClinicalTrials.gov Identifier:	NCT00286130
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Central European Cooperative Oncology Group:

metastatic colorectal cancer
FOLFOX 6
FOLFIRI

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Cetuximab
Colonic Diseases
Irinotecan
Leucovorin
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal 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