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OpenTrials
Completed

NCT Number: NCT00061815

Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer

The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ImClone Investigational Site, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented colorectal cancer which is EGFR-positive and is metastatic.
  • Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.

Exclusion criteria

  • A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Known metastases in the central nervous system.
  • Symptomatic sensory or peripheral neuropathy.
  • More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer.
  • Prior oxaliplatin therapy.
  • Prior cetuximab or other therapy which targets the EGF pathway.
  • Prior chimerized or murine monoclonal antibody therapy.

Treatment and study plan

Cetuximab

Biological

400 mg/m2 IV

Other names: Erbitux™

Oxaliplatin

Drug

85 mg/m2 IV

Other names: Eloxatin®

Leucovorin

Drug

200 mg/m2 IV

Other names: Wellcovorin®

5-fluorouracil

Drug

400 mg/m2 IV

Other names: 5-FU

Primary outcomes

  1. Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone.

    Time frame: Every six weeks

Secondary outcomes

  1. Compare the response rates between the two treatment arms.

    Time frame: Every six weeks

  2. Compare progression-free survival between the two treatment arms.

    Time frame: Every six weeks

  3. Duration of response within each treatment arm.

    Time frame: Every six weeks

  4. Time to response within each treatment arm.

    Time frame: Every six weeks

  5. Compare the safety profiles between the two treatment arms.

    Time frame: Every six weeks

  6. Compare the quality of life (QOL)between the two treatment arms.

    Time frame: Every six weeks

  7. Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms.

    Time frame: Every six weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Phase 3 Randomized Multicenter Study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, and Leucovorin in Subjects With Previously Treated Metastatic, EGFR-Positive Colorectal Carcinoma

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Jun 6, 2003
Registry last updated
Apr 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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