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Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
FOLFOX 6
FOLFIRI
Sponsored by
Central European Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring metastatic colorectal cancer, FOLFOX 6, FOLFIRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LKH Leoben, Abt. für Innere Medizin
  • Univ. Klinik für Innere Medizin I
  • Institute of Oncology
  • University Hospital "Queen Joanna"
  • SBALO National Oncology Center
  • University Hospital for Tumors
  • University Hospital Rebro
  • Bank of Cyprus Oncology Center
  • Univ. Hospital Brno, Dept. Of Clinical Oncology
  • Charles University Prague, Dep. of Oncology
  • National Medical Center
  • Markusovsy Hospital
  • Csolnoky Ferenc County Hospital
  • Hadassah Medical Center
  • Souraski Medical Center
  • Hospital Amadora Sintra, Servico de Oncologia
  • Hospital de Beja
  • Hospital Distrital de Faro
  • Hospital Geral de Sto. António
  • Hospital San Teotóno -
  • Institutul Oncologic Bucuresti
  • Institutul Oncologic Cluj
  • National Cancer Institute
  • Institute of Oncology
  • Ankara Hacettepe University, Oncology Unit
  • Gazi University Medical Faculty
  • 9 Eyul University Medical Faculty, Dep of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

FOLFOX 6

FOLFIRI

Arm Description

FOLFOX 6: Oxaliplatin 100 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:

FOLFIRI: Irinotecan 180 mg/m² day 1 concurrent with Leucovorin 400 mg/m² followed by Bolus 5FU 400 mg/m², followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks

Outcomes

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

Full Information

First Posted
February 2, 2006
Last Updated
April 30, 2012
Sponsor
Central European Cooperative Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00286130
Brief Title
Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central European Cooperative Oncology Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
metastatic colorectal cancer, FOLFOX 6, FOLFIRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOLFOX 6
Arm Type
Active Comparator
Arm Description
FOLFOX 6: Oxaliplatin 100 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
Arm Title
FOLFIRI
Arm Type
Active Comparator
Arm Description
FOLFIRI: Irinotecan 180 mg/m² day 1 concurrent with Leucovorin 400 mg/m² followed by Bolus 5FU 400 mg/m², followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
Intervention Type
Drug
Intervention Name(s)
FOLFOX 6
Intervention Description
FOLFOX 6: Oxaliplatin 100 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
FOLFIRI: Irinotecan 180 mg/m² day 1 concurrent with Leucovorin 400 mg/m² followed by Bolus 5FU 400 mg/m², followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
Primary Outcome Measure Information:
Title
the percentage of patients surviving without disease progression in each arm at 9 months
Secondary Outcome Measure Information:
Title
PFS rates at 3,6,12 months
Title
Response rates
Title
Overall survival (OS) in each arm
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Scheithauer, MD
Organizational Affiliation
Dep. of Internal Medicine I, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
LKH Leoben, Abt. für Innere Medizin
City
Leoben
State/Province
Steiermark
ZIP/Postal Code
8700
Country
Austria
Facility Name
Univ. Klinik für Innere Medizin I
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Institute of Oncology
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Hospital "Queen Joanna"
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
Facility Name
SBALO National Oncology Center
City
Sofia
ZIP/Postal Code
1754
Country
Bulgaria
Facility Name
University Hospital for Tumors
City
Zagreb
Country
Croatia
Facility Name
University Hospital Rebro
City
Zagreb
Country
Croatia
Facility Name
Bank of Cyprus Oncology Center
City
Nikosia
Country
Cyprus
Facility Name
Univ. Hospital Brno, Dept. Of Clinical Oncology
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Charles University Prague, Dep. of Oncology
City
Prague
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
National Medical Center
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Markusovsy Hospital
City
Szomathely
ZIP/Postal Code
39700
Country
Hungary
Facility Name
Csolnoky Ferenc County Hospital
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Souraski Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Hospital Amadora Sintra, Servico de Oncologia
City
Amadora
ZIP/Postal Code
2720
Country
Portugal
Facility Name
Hospital de Beja
City
Beja
ZIP/Postal Code
78000
Country
Portugal
Facility Name
Hospital Distrital de Faro
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Hospital Geral de Sto. António
City
Porto
ZIP/Postal Code
4000-377
Country
Portugal
Facility Name
Hospital San Teotóno -
City
Viseu
Country
Portugal
Facility Name
Institutul Oncologic Bucuresti
City
Bucuresti
Country
Romania
Facility Name
Institutul Oncologic Cluj
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
National Cancer Institute
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
Institute of Oncology
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Ankara Hacettepe University, Oncology Unit
City
Ankara
Country
Turkey
Facility Name
Gazi University Medical Faculty
City
Ankara
Country
Turkey
Facility Name
9 Eyul University Medical Faculty, Dep of Oncology
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

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