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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

Primary Purpose

Metastatic Colorectal Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine and cetuximab
Sponsored by
Translational Genomics Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Evergreen Hematology & Oncology

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population
To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.

Full Information

First Posted
July 17, 2009
Last Updated
October 18, 2022
Sponsor
Translational Genomics Research Institute
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00954876
Brief Title
Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prematurely, prior to enrollment of first participant
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Genomics Research Institute
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesh Ramanathan, M.D.
Organizational Affiliation
Translational Genomics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evergreen Hematology & Oncology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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