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A Phase II Trial of Cetuximab Plus Irinotecan as a 2nd-line Treatment in Patients With Metastatic Colorectal Cancer After Failure to Irinotecan That Express Wild-type KRAS With and Without Detectable EGFR Expression


Phase 2
18 Years
75 Years
Not Enrolling
Both
Advanced Colorectal Cancer

Thank you

Trial Information

A Phase II Trial of Cetuximab Plus Irinotecan as a 2nd-line Treatment in Patients With Metastatic Colorectal Cancer After Failure to Irinotecan That Express Wild-type KRAS With and Without Detectable EGFR Expression


Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will
be accrued in this study. All patients should have wild-type KRAS.


Inclusion Criteria:



- Colorectal adenocarcinoma, Wild KRAS, 18-75 yr

- Estimated life expectancy of more than 3 months

- ECOG performance status of 0 to 1 at study entry

- Adequate bone marrow function

- Adequate liver function

- Documented progression during or within 3 months of irinotecan-containing regimens as
a first-line chemotherapy

- Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx
Kit

- Informed Consent

Exclusion Criteria:

- Central nervous system (CNS) metastases or prior radiation for CNS metastases.

- Intestinal obstruction or impending intestinal obstruction due to peritoneal
carcinomatosis

- Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the
study.

- Evidence of gastrointestinal bleeding

- Exposure to Cetuximab

- Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or
EGFR-targeted treatment

- KRAS mutant Status

- Patients with serious toxicity to previous irinotecan-based chemotherapy

- Other serious illness or medical conditions

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

8 week

Safety Issue:

Yes

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

AMC-ONCGI-2008-0031

NCT ID:

NCT00637091

Start Date:

March 2008

Completion Date:

September 2011

Related Keywords:

  • Advanced Colorectal Cancer
  • Colorectal Neoplasms

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