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

October 18, 2022 updated by: Translational Genomics Research Institute

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology & Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
Time Frame: 18 months
18 months
To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
Time Frame: 18 months
18 months
To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population
Time Frame: every three months
every three months
To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.
Time Frame: 1 year after study closure
1 year after study closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Genomics Research Institute

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Ramesh Ramanathan, M.D., Translational Genomics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

July 17, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (ESTIMATE)

August 7, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-P02-07003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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