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Cetuximab Monotherapy Maintenance Treatment in mCRC

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Cetuximab

mFOLFOX6

FOLFIRI

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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

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

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

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

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

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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