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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This study has been withdrawn prior to enrollment.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:
TGen Drug Development Services
ClinicalTrials.gov Identifier:
NCT00954876
First received: July 17, 2009
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Cancer
 Drug: capecitabine and cetuximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TGen Drug Development Services:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954876

Locations
United States, Washington
Evergreen Hematology & Oncology
Spokane, Washington, United States, 99218
Sponsors and Collaborators
TGen Drug Development Services
ImClone LLC
Investigators
Principal Investigator: Ramesh Ramanathan, M.D. TGen Drug Development Services
  More Information

No publications provided

Responsible Party: Ramesh Ramanathan, M.D. Principal Investigator, TGen Drug Development Services
ClinicalTrials.gov Identifier: NCT00954876     History of Changes
Other Study ID Numbers: MED-P02-07003
Study First Received: July 17, 2009
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
 Fluorouracil
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013