NCT00954876

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

July 17, 2009

Last Update Submit

October 18, 2022

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

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

    18 months

Secondary Outcomes (4)

  • To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab

    18 months

  • To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab

    18 months

  • To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population

    every three months

  • To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.

    1 year after study closure

Interventions

capecitabine and cetuximabDRUG

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evergreen Hematology & Oncology

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

CapecitabineCetuximab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ramesh Ramanathan, M.D.

    Translational Genomics

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2009

First Posted

August 7, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(1)