Cetuximab Monotherapy Maintenance Treatment in mCRC

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Drug: Cetuximab; Drug: mFOLFOX6; Drug: FOLFIRI

• Registration Number: NCT02978313
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2016-09-08
• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-29
• Last Update Submitted: 2016-11-29
• Study First Posted: 2016-11-30
• Last Update Posted: 2016-11-30
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cet+chemo continuation	FOLFIRI	Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
Cet+chemo continuation	Cetuximab	Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
Cet+chemo continuation	mFOLFOX6	Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
Cet maintenance	Cetuximab	Cetuximab maintenance treatment following induction treatment

Primary Outcome Measures

Name	Time	Method
PFS	4-6 months

Secondary Outcome Measures

Name	Time	Method
OS	22 months
QoL	22 months