Cetuximab Monotherapy Maintenance Treatment in mCRC

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02978313
• Other study ID #: RJH-Cet-Maintenance
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: September 8, 2016
• Last updated: November 29, 2016
• Start date: November 2016
• Est. completion date: November 2019

Study information

• Verified date: November 2016
• Source: Ruijin Hospital
• Contact: Jun Zhang, PhD
• Phone: +-86-18917762326
• Email: junzhang[@]188.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Cetuximab
anti-EGFR monoclonal antibody
• mFOLFOX6
Oxaliplatin+LV5FU2
• FOLFIRI
Irinotecan+LV5FU2

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Ruijin Hospital	Henan Cancer Hospital, Jiangsu Cancer Institute & Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University

References & Publications (2)

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. — View Citation

Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		4-6 months	Yes
Secondary	OS		22 months	Yes
Secondary	QoL		22 months	Yes