Folfirinox + Cetuximab Chemotherapy, in First Line, With Wild RAS and According to BRAF Status in Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

— ESTER  

Official title:

A Retrospective Study Assessing the Efficacy and Safety of Triplet Chemotherapy (FOLFIRINOX) Fluorouracil + Oxaliplatin + Irinotecan Plus Cetuximab (ERBITUX®) as First Line Treatment in a RAS (Ras Sarcoma Viral Oncogene Homolog) (KRAS, NRAS) Wild-type Metastatic Colorectal Cancer Population According to BRAF (Murine Sarcoma Viral Oncogene Homolog B) Status and Primary Tumor Location

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914170
• Other study ID #: ICM-URC2016/31
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: September 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

Description:

In Europe, there are 447,000 new cases of colorectal cancer each year. Approximately 25% of patients present with metastases at initial diagnosis and almost 50% of patients with mCRC (metastatic colorectal cancer) will develop metastases . Chemotherapy represents the backbone of treatment, and survival is linked with the administration of all three active cytotoxic agents (5-fluorouracil/folinate, oxaliplatin, and irinotecan) in the first line treatment of metastatic colorectal disease. Monoclonal antibodies such as cetuximab in combination with chemotherapy are a first line treatment option in metastatic RAS (rat sarcoma viral oncogene homolog) wild type metastatic colorectal cancer (mCRC). Phase II trials evaluating triplet chemotherapy plus cetuximab reported interesting results in terms of efficacy (response rate, resectability...), but at the price of an increased rate of toxic effects. This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type mCRC (metastatic colorectal cancer) population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Colorectal cancer confirmed as RAS wild by tumor tissue analysis

2. Non resectable and measurable metastatic disease

3. Patients treated with FOLFIRINOX + cetuximab in first line metastatic disease

4. Males or females aged over 18 years.

Exclusion Criteria:

1. Known brain metastases

2. RAS not assessable (e.g., material not available or insufficient)

3. The first administration of cetuximab was more than 30 days after the first administration of FOLFIRINOX

4. History of other malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Folfirinox + cetuximab
Cetuximab 250 mg/m² iv infusion for 2h, Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h, Irinotecan 180 mg/m² iv infusion, 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles max)

Locations

Country	Name	City	State
France	Institut régional du cancer de Montpellier	Montpellier	Hérault

Sponsors (2)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle	Merck Serono International SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Progression free survival (PFS)	In RAS wt population	Approximately 36 months
Secondary	Progression free survival (PFS)	Rates in RAS wt population	9 months
Secondary	Overall Response Rate	at the end of 1st line treatment evaluated according RECIST ( Response Evaluation Criteria in Solid Tumours)	Maximal 6 months
Secondary	Overall Survival	Defined as the time from the date of initial first line treatment initiation to the date of documented death from any cause	Approximately 36 months
Secondary	Duration of response		Approximately 36 months
Secondary	Assessment of adverse events by using the NCI-CTCAE version 4.0 scale	Maximum grade observed throughout the treatment	Maximal 6 months
Secondary	Liver metastases resection rate	Resection (R0 / R1 / R2)	Maximal 6 months