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FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor

Primary Purpose

Metastatic Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Cetuximab (Erbitux)

Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Erbitux, Colorectal cancer, Oxaliplatin, Flox, Fluorouracil + folinic acid, K-RAS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histology and staging disease:

Histological proven adenocarcinoma of the colon or rectum
At least one measurable metastatic lesion according to RECIST criteria
If only one metastatic lesion, histology is mandatory

Mutation level:

Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR

General conditions:

Age >18 and < 75 years
WHO performance status ≤ 2; life expectancy of more than 3 months
Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L)
Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases
Written informed consent prior to randomisation must be obtained and documented according to the local regulatory requirements

Other:

Fertile patients must use adequate contraceptives

Exclusion Criteria:

Prior therapy:

Prior chemotherapy for advanced/metastatic disease
Adjuvant chemotherapy must have ended > 6 months before inclusion
Prior treatment with Eloxatin
Prior treatment with Erbitux or other treatment to EGFR

Prior or current history:

Current indication for resection with a curative intent
Evidence of CNS metastasis
Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis
Current history of chronic diarrhea
Peripheral neuropathy
Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies)
Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix

Concomitant treatments:

Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation
Concurrent treatment with any other anti-cancer therapy

Other:

Pregnant or breast feeding women

Sites / Locations

Department of Oncology, Aalborg University Hospital
Department of Oncology, Herlev University Hospital
Department of Oncology, Odense University Hospital
Department of Oncology, Haukeland University Hospital
Kreftsenteret, Ullevaal University Hospital
Section of Oncology, Uppsala University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00660582

First Posted

April 11, 2008

Last Updated

January 20, 2015

Sponsor

Per Pfeiffer

Collaborators

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00660582

Brief Title

FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor

Official Title

FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Per Pfeiffer

Collaborators

Odense University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or C). Effect-data has not yet been published but the combination is well tolerated, and other studies have shown that Erbitux administered with chemotherapy seem to be more efficient than chemotherapy alone. The main purpose with this study is to investigate the effect of FLOX and Erbitux given every second week as first line treatment for patients with metastatic colorectal cancer and K-RAS wildtype tumor. The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

Erbitux, Colorectal cancer, Oxaliplatin, Flox, Fluorouracil + folinic acid, K-RAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cetuximab (Erbitux)

Intervention Description

500 mg/m² every second week, intravenous infusion, 8 cycles

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid

Intervention Description

Given in combination day 1 and 2, every second week, 8 cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histology and staging disease: Histological proven adenocarcinoma of the colon or rectum At least one measurable metastatic lesion according to RECIST criteria If only one metastatic lesion, histology is mandatory Mutation level: Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR General conditions: Age >18 and < 75 years WHO performance status ≤ 2; life expectancy of more than 3 months Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L) Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases Written informed consent prior to randomisation must be obtained and documented according to the local regulatory requirements Other: Fertile patients must use adequate contraceptives Exclusion Criteria: Prior therapy: Prior chemotherapy for advanced/metastatic disease Adjuvant chemotherapy must have ended > 6 months before inclusion Prior treatment with Eloxatin Prior treatment with Erbitux or other treatment to EGFR Prior or current history: Current indication for resection with a curative intent Evidence of CNS metastasis Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis Current history of chronic diarrhea Peripheral neuropathy Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies) Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix Concomitant treatments: Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation Concurrent treatment with any other anti-cancer therapy Other: Pregnant or breast feeding women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Per Pfeiffer, MD

Organizational Affiliation

Odense University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Aalborg University Hospital

City

Aalborg

ZIP/Postal Code

9800

Country

Denmark

Facility Name

Department of Oncology, Herlev University Hospital

City

Herlev

ZIP/Postal Code

2630

Country

Denmark

Facility Name

Department of Oncology, Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Department of Oncology, Haukeland University Hospital

City

Bergen

Country

Norway

Facility Name

Kreftsenteret, Ullevaal University Hospital

City

Oslo

ZIP/Postal Code

0407

Country

Norway

Facility Name

Section of Oncology, Uppsala University Hospital

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor

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