Erbitux (Cetuximab) Given Alone to Patients With EGFR-Negative Metastatic Colon or Rectal Cancer That is Refractory to Chemotherapy
Public ClinicalTrials.gov record NCT00083720. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Refractory, EGFR-Negative Metastatic Colorectal Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase II, multicenter, open-label study of cetuximab in patients with epidermal growth factor receptor (EGFR) negative, metastatic colorectal carcinoma who have progressed after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine. Target enrollment is 80 evaluable patients. Patients with EGFR-negative metastatic colorectal carcinoma who have progressed after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine, will receive an initial dose of cetuximab, 400 mg/m2 , intravenously (i.v.) over 120 minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who experience unacceptable toxicity or who have progressive disease (PD) will not receive further cetuximab therapy. Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy. Patients with stable disease (SD), partial response (PR), or a complete response (CR) may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a PR or CR must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response. To evaluate the objective response rate, a single-stage design will be used in this study.
Study identification
- NCT ID
- NCT00083720
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 87 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2004 (Type not available)
- Primary completion
- Apr 2008 (Actual)
- Completion
- Apr 2008 (Actual)
- Last update posted
- May 25, 2011
2004 – 2008
United States locations
- U.S. sites
- 23
- U.S. states
- 13
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ImClone Investigational Site | Campbell | California | 95008 | — |
| ImClone Investigational Site | Los Angeles | California | 90033 | — |
| ImClone Investigational Site | Soquel | California | 95073 | — |
| ImClone Investigational Site | Jacksonville | Florida | 32256 | — |
| ImClone Investigational Site | Orlando | Florida | 32804 | — |
| ImClone Investigational Site | Ormond Beach | Florida | 32174 | — |
| ImClone Investigational Site | Gurnee | Illinois | 60031 | — |
| ImClone Investigational Site | Evansville | Indiana | 47714 | — |
| ImClone Investigational Site | Indianapolis | Indiana | 46202 | — |
| ImClone Investigational Site | Lexington | Kentucky | 40503 | — |
| ImClone Investigational Site | Louisville | Kentucky | 40202 | — |
| ImClone Investigational Site | Metairie | Louisiana | 70006 | — |
| ImClone Investigational Site | Boston | Massachusetts | 02114 | — |
| ImClone Investigational Site | Ann Arbor | Michigan | 48106-0995 | — |
| ImClone Investigational Site | Kalamazoo | Michigan | 49048 | — |
| ImClone Investigational Site | St Louis | Missouri | 63110 | — |
| ImClone Investigational Site | Armonk | New York | 10504 | — |
| ImClone Investigational Site | East Setauket | New York | 11733 | — |
| ImClone Investigational Site | Durham | North Carolina | 27710 | — |
| ImClone Investigational Site | Sellingsgrove | Pennsylvania | 17870 | — |
| ImClone Investigational Site | Arlington | Texas | 76012 | — |
| ImClone Investigational Site | Bryan | Texas | 77802 | — |
| ImClone Investigational Site | Temple | Texas | 76508 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00083720, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 25, 2011 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00083720 live on ClinicalTrials.gov.