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Phase II/III Trial of Cetuximab Plus Irinotecan Synchronously/Subsequently in Patients With KRAS Wild-type Metastatic Colorectal Cancer: an Randomized, Open-label, Multicenter, Prospective Study


Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

Phase II/III Trial of Cetuximab Plus Irinotecan Synchronously/Subsequently in Patients With KRAS Wild-type Metastatic Colorectal Cancer: an Randomized, Open-label, Multicenter, Prospective Study


CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds
specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a
murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is
expressed by Chinese hamster ovary cells. It is a biosimilar of cetuximab (C225, Erbitux®)
and it is developed by NERCAM and produced by Biomabs. Phase I study results suggest that
CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter,
open-label study was to determine whether adding cetuximab (CMAB009) to irinotecan increased
the response rate and prolongs survival in patients with KRAS wild-type metastatic
colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.


Inclusion Criteria:



- histologically confirmed metastatic colorectal adenocarcinoma

- KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;

- has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre
by physical examination or other iconography

- ECOG performance status 0 to 1

- Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and
oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve

Exclusion Criteria:

- Previous irinotecan or anti-EGFR therapies were excluded

- hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less
than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic
millimeter

- liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate
aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the
upper limit of normal with hepatic metastasis or not

- Renal function: serum creatinine, more than 1.5 times the upper limit of normal

- Patients with symptomatic central nervous system metastases were excluded

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

Tumor response was evaluated every 6 weeks and confirmed at least 4 weeks later

Outcome Time Frame:

Time to progression, assessed up to two years

Safety Issue:

Yes

Principal Investigator

S Y Kai

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital, Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

CMAB009mCRCⅡ/Ⅲ

NCT ID:

NCT01550055

Start Date:

March 2009

Completion Date:

December 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • KRAS wild-type
  • Metastatic Colorectal Cancer
  • CMAB009 Plus Irinotecan
  • Phase II/III
  • Colorectal Neoplasms

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