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Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/Irinotecan Regimen


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/Irinotecan Regimen

Inclusion Criteria


Inclusion Criteria

- Metastatic colorectal cancer

- Tumor classified WT KRAS

- At least 18 yrs of age

- ECOG PS 0,1 or 2

- Evidence of adequate organ function

- Measurable disease per RECIST criteria

- Have at least two of the following criteria:

- Age > 65 years

- ECOG PS 1 or 2

- Serum Albumin < or equal to 3.5g/dL

- Prior RT to abdomen or pelvis

- Stopped first-line combination systemic chemotherapy < 6 weeks duration

Exclusion Criteria

- Tumors classified as KRAS mutation

- Prior therapy with cetuximab, panitumumab or other agent that targets EGFR

- Prior exposure to any biologic

- Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)

- Known DPD deficiency

- Uncontrolled angina or a myocardial infarction within the previous 12 months

- Concurrent severe uncontrolled medical illness

- Known uncontrolled CNS metastases

- Bowel disease associated with chronic diarrhea

- Major surgery within 28 days

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:

Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Ramesh Ramanathan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

TGen Drug Development Services

Authority:

United States: Institutional Review Board

Study ID:

MED-P02-07003

NCT ID:

NCT00954876

Start Date:

August 2009

Completion Date:

January 2010

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Evergreen Hematology & OncologySpokane, Washington  99218