Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer

This study has been withdrawn prior to enrollment.
(Study has been terminated due to lack of accrual.)
Sponsor:
Collaborator:
ImClone LLC
Information provided by:
Translational Drug Development
ClinicalTrials.gov Identifier:
NCT00954876
First received: July 17, 2009
Last updated: January 27, 2012
Last verified: January 2012

July 17, 2009
January 27, 2012
August 2009
January 2010   (final data collection date for primary outcome measure)
Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00954876 on ClinicalTrials.gov Archive Site
  • To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population [ Time Frame: every three months ] [ Designated as safety issue: Yes ]
  • To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy. [ Time Frame: 1 year after study closure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer
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

The combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan combination therapy are eligible for this study.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
Drug: capecitabine and cetuximab

Cetuximab 500 mg/m2 IV infusion over 1-2 hours Once every 2 weeks

Capecitabine 1500 mg/m2 PO BID Days 1-7 followed by 7 days of no treatment and repeated every 2 weeks

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00954876
MED-P02-07003
No
Ramesh Ramanathan, M.D. Principal Investigator, TGen Drug Development Services
Translational Drug Development
ImClone LLC
Principal Investigator: Ramesh Ramanathan, M.D. Translational Drug Development
Translational Drug Development
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP