Clinical Trials /

Cetuximab Maintenance Treatment Versus Continuation After Induction Therapy in mCRC

NCT02942706

Description:

This study is try to evaluate the effect of cetuximab monotherapy as maintenance treatment, versus continuation after 8 courses of induction therapy with cetuximab plus standard chemotherapy regimen (FOLFIRI or mFOLFOX6)in metastatic colorectal cancer (mCRC) patients. The maintenance treatments are continued until disease progression or untolerated toxicity. The aim of this study is to demonstrate that cetuximab monotherapy is non-inferior to continuation treatment, in those mCRC patients who responded to induction therapy(SD, PR, or CR), and carry biomarker-panels (KRAS, NRAS, BRAF, and PIK3CA) favor EGFR antibody.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Cetuximab Maintenance Treatment Versus Continuation After Induction Therapy in mCRC
  • Official Title: Biomarker-Panel Guided Maintenance Treatment With Cetuximab Monotherapy Versus Continuation After First Line Induction Therapy of Metastatic Colorectal Cancer (mCRC) : a Multicenter, Prospective, Randomized Controlled Trial

Clinical Trial IDs

  • ORG STUDY ID: BLOC-1
  • NCT ID: NCT02942706

Conditions

  • Colorectal Cancer

Interventions

DrugSynonymsArms
CetuximabErbituxCet maintenance
mFOLFOX6Cet+chemo continuation
FOLFIRICet+chemo continuation

Purpose

This study is try to evaluate the effect of cetuximab monotherapy as maintenance treatment, versus continuation after 8 courses of induction therapy with cetuximab plus standard chemotherapy regimen (FOLFIRI or mFOLFOX6)in metastatic colorectal cancer (mCRC) patients. The maintenance treatments are continued until disease progression or untolerated toxicity. The aim of this study is to demonstrate that cetuximab monotherapy is non-inferior to continuation treatment, in those mCRC patients who responded to induction therapy(SD, PR, or CR), and carry biomarker-panels (KRAS, NRAS, BRAF, and PIK3CA) favor EGFR antibody.

Detailed Description

      This study is try to evaluate the effect of cetuximab monotherapy as maintenance treatment,
      versus continuation after 8 courses of induction therapy with cetuximab plus standard
      chemotherapy regimen (FOLFIRI or mFOLFOX6)in metastatic colorectal cancer (mCRC) patients.
      The maintenance treatments are continued until disease progression or untolerated toxicity.
      The aim of this study is to demonstrate that cetuximab monotherapy is non-inferior to
      continuation treatment, in those mCRC patients who responded to induction therapy(SD, PR, or
      CR), and carry biomarker-panels (KRAS, NRAS, BRAF, and PIK3CA) favor EGFR antibody.
      Furthermore, the mutation status of biomarker panel consist of KRAS, NRAS, HRAS, BRAF, EGFR,
      ERBB2, ERBB3, PIK3CA, PTEN, SMAD4, SMAD2, TGFBR2, cMET, Src, mTOR, VEGFR1, VEGFR2, EPHA2,
      MSI, TP53, ERCC1, ERCC5, KCNQ5, ILK, and Myc will be analyzed by NGS sequencing. The ctDNA as
      surrogate marker via liquid biopsy will be conducted before randomization, during maintenance
      treatment, and disease progression.
    

Trial Arms

NameTypeDescriptionInterventions
Cet maintenanceExperimentalCetuximab maintenance treatment following induction treatment
  • Cetuximab
Cet+chemo continuationActive ComparatorCetuximab plus continuation mFOLFOX6/FOLFIRI regimens
  • Cetuximab
  • mFOLFOX6
  • FOLFIRI

Eligibility Criteria

        Before the start of induction therapy:

        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 which are either technically unresectable or no chance to reach NED
             (patients with only local recurrence are not eligible);

          -  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;

          -  Ongoing or planned first line induction therapy with 8 cycles of FOLFIRI or mFOLFOX6.

        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

          -  RAS mutant mCRC

        At randomisation:

        Inclusion criteria:

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

          -  Disease evaluation with proven SD, PR or CR according to RECIST after 8 cycles of
             FOLFIRI or mFOLFOX6;

          -  Laboratory values obtained ≤ 2 weeks prior to randomisation: adequate bone marrow
             function (Hb > 8.0 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);

          -  Life expectancy > 24 weeks;

          -  Age: 18-75 years;

          -  Negative pregnancy test in women with childbearing potential;

          -  Expected adequacy of follow-up;

          -  Institutional Review Board approval;

          -  Written informed consent Exclusion criteria

          -  Chronic active infection;

          -  Any other concurrent severe or uncontrolled disease preventing the safe administration
             of study drugs;
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival 1 (PFS1)
Time Frame:4 months
Safety Issue:
Description:from randomization to progression

Secondary Outcome Measures

Measure:Progression Free Survival 2 (PFS2)
Time Frame:10 months
Safety Issue:
Description:from signing informed consent to progression
Measure:Overall Survival (OS)
Time Frame:24 months
Safety Issue:
Description:from signing informed consent to death
Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame:24 months
Safety Issue:
Description:drug related toxicity from signing informed consent to death
Measure:Quality of life (QoL)
Time Frame:24 months
Safety Issue:
Description:QoL from signing informed consent to death

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Ruijin Hospital

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