Cetuximab Monotherapy Maintenance Treatment in mCRC
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cetuximab
mFOLFOX6
FOLFIRI
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cet maintenance
Cet+chemo continuation
Arm Description
Cetuximab maintenance treatment following induction treatment
Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
Outcomes
Primary Outcome Measures
PFS
Secondary Outcome Measures
OS
QoL
Full Information
NCT ID
NCT02978313
First Posted
September 8, 2016
Last Updated
November 29, 2016
Sponsor
Ruijin Hospital
Collaborators
Jiangsu Cancer Institute & Hospital, Henan Cancer Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT02978313
Brief Title
Cetuximab Monotherapy Maintenance Treatment in mCRC
Official Title
Biomarker-Panel Enriched Maintenance Treatment With Cetuximab Monotherapy Versus Continuation After Induction Treatment With Chemotherapy + Cetuximab in Metastatic Colorectal Cancer (mCRC)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Jiangsu Cancer Institute & Hospital, Henan Cancer Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cet maintenance
Arm Type
Experimental
Arm Description
Cetuximab maintenance treatment following induction treatment
Arm Title
Cet+chemo continuation
Arm Type
Active Comparator
Arm Description
Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
erbitux
Intervention Description
anti-EGFR monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6
Intervention Description
Oxaliplatin+LV5FU2
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
Irinotecan+LV5FU2
Primary Outcome Measure Information:
Title
PFS
Time Frame
4-6 months
Secondary Outcome Measure Information:
Title
OS
Time Frame
22 months
Title
QoL
Time Frame
22 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhang, PhD
Phone
+-86-18917762326
Email
junzhang@188.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yifeng Wang, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22473155
Citation
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.
Results Reference
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PubMed Identifier
19339720
Citation
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.
Results Reference
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Cetuximab Monotherapy Maintenance Treatment in mCRC
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