Cetuximab Monotherapy Maintenance Treatment in mCRC

Biomarker-Panel Enriched Maintenance Treatment With Cetuximab Monotherapy Versus Continuation After Induction Treatment With Chemotherapy + Cetuximab in Metastatic Colorectal Cancer (mCRC)

Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of progression.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Cetuximab; Drug: mFOLFOX6; Drug: FOLFIRI

Detailed Description

Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of progression. This treatment is continued until progression or severe toxicity.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained);
• Distant metastases (patients with only local recurrence are not eligible);
• Unidimensionally measurable disease (> 1 cm on spiral CT scan or > 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation;
• In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field;
• Ongoing or planned first line treatment with 6 cycles of mFOLFOX6/FOLFIRI plus Cetuximab.

At randomisation:

• WHO performance status 0-1 (Karnofsky PS > 70%);

• Laboratory values obtained ≤ 2 weeks prior to randomisation:

  • adequate bone marrow function (Hb > 6.0 mmol/L, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L),
  • renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, > 30 ml/min),
  • liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases);
• Negative pregnancy test in women with childbearing potential;
• Expected adequacy of follow-up;
• Institutional Review Board approval;
• Written informed consent Exclusion criteria;
• History or clinical signs/symptoms of CNS metastases;
• History of a second malignancy ≤ 5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin.

Exclusion Criteria:

• Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment;
• Any prior adjuvant treatment after resection of distant metastases;
• Previous systemic treatment for advanced disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cet maintenance; Cetuximab maintenance treatment following induction treatment	Drug: Cetuximab; anti-EGFR monoclonal antibody; Other Names: erbitux
Active Comparator: Cet+chemo continuation; Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens	Drug: Cetuximab; anti-EGFR monoclonal antibody; Other Names: erbitux; Drug: mFOLFOX6; Oxaliplatin+LV5FU2; Drug: FOLFIRI; Irinotecan+LV5FU2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PFS	4-6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
OS	22 months
QoL	22 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Henan Cancer Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Jiangsu Cancer Institute & Hospital
• Investigators: Principal Investigator: Yifeng Wang, MD, Ruijin Hospital

Publications and helpful links

General Publications

• Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.
• Tveit KM, Guren T, Glimelius B, Pfeiffer P, Sorbye H, Pyrhonen S, Sigurdsson F, Kure E, Ikdahl T, Skovlund E, Fokstuen T, Hansen F, Hofsli E, Birkemeyer E, Johnsson A, Starkhammar H, Yilmaz MK, Keldsen N, Erdal AB, Dajani O, Dahl O, Christoffersen T. Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer: the NORDIC-VII study. J Clin Oncol. 2012 May 20;30(15):1755-62. doi: 10.1200/JCO.2011.38.0915. Epub 2012 Apr 2.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Estimate): November 30, 2016
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: RJH-Cet-Maintenance

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO