Trial · NCT00083720
Erbitux (Cetuximab) Given Alone to Patients With EGFR-Negative Metastatic Colon or Rectal Cancer That is Refractory to Chemotherapy
NCT00083720, Phase 2, Completed, Eli Lilly and Company; results first posted 2009-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erbitux (Cetuximab) Given Alone to Patients With EGFR-Negative Metastatic Colon or Rectal Cancer That is Refractory to Chemotherapy. Trials, record NCT00083720. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00083720
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erbitux (Cetuximab) Given Alone to Patients With EGFR-Negative Metastatic Colon or Rectal Cancer That is Refractory to Chemotherapy
- NCT number
- NCT00083720
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Colorectal Neoplasms, Metastases, Neoplasm
- Interventions
- cetuximab
- First posted
- 2004-06-02
- Last updated
- 2011-05-25
- Results first posted
- 2009-10-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an Overall Resonse | Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation. | Determine the response rate (complete response \[CR\] and partial response \[PR\]) in patients with epidermal growth factor receptor (EGFR)-negative metastatic colorectal carcinoma treated with cetuximab, as classified by the investigator according to the World Health Organization (WHO) criteria. The calculation was the total number of patients with CR or PR divided by the total number of patients treated. |
| Primary | Number of Participants With Adverse Events | An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. | Reported adverse events (AEs) per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities dictionary. The National Cancer Insititute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated). |
| Primary | Number of Participants With Serious Adverse Events | A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. | Reported SAEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities. The NCI-CTCAE Version 3.0 was used to grade all SAEs. An SAE was any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, was life threatening, required inpatient hospitalization or caused prolongation of existing hospitalization,congenital anomaly/birth defect, or any important medical event. |
| Secondary | Percentage of Participants With Disease Control (CR, PR, or SD) | Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response. | This is the total number of patients with a best overall response of CR, PR, and stable disease (SD) divided by the total number of patients treated. |
| Secondary | Duration of Response | The duration of response was measured from the date of response to the first date of PD (range 2 to 7 months). | In patients with a best overall response of CR or PR, the duration of response is measured from the date criteria are first met for CR or PR, until the first date that Progressive Disease (PD) is objectively documented or death occurs. Duration of response of living patients with no evidence of PD was censored on the date of their last tumor assessment. |
| Secondary | Time to Progression | Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine (range: 1-3 months). | This measure was defined as the time from the first day of treatment until the date of PD. Deaths without objective progression were censored. Patients who did not progress were censored at their last day of tumor assessment. |
| Secondary | Overall Survival | Survival information was collected every 3 months after completion of therapy and/or follow-up up to 24 months. | This measure is defined as the time from the first day of therapy to the date of death. Survival of living patients or those lost to follow-up were censored on the last date the patients were known to be alive. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an Overall Resonse | Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation. | The overall response rate was calculated for the modified Intent to Treat (mITT) population. | percentage of participants | MEAN |
| SECONDARY | Percentage of Participants With Disease Control (CR, PR, or SD) | Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response. | Disease control rate was the total number of patients with best overall response of CR, PR and SD divided by the total number of patients treated. | Percentage of participants | MEAN |
| SECONDARY | Duration of Response | The duration of response was measured from the date of response to the first date of PD (range 2 to 7 months). | The duration of response was calculated for the subgroup of the mITT population who demonstrated a response. | Months | MEDIAN |
| SECONDARY | Time to Progression | Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine (range: 1-3 months). | This measure was calculated for the mITT population. | Months | MEDIAN |
| SECONDARY | Overall Survival | Survival information was collected every 3 months after completion of therapy and/or follow-up up to 24 months. | Overall survival was calculated from the time of the first day of therapy to the date of death for the mITT population. | Months | MEDIAN |
| PRIMARY | Number of Participants With Adverse Events | An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. | Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses. | Participants | NUMBER |
| PRIMARY | Number of Participants With Serious Adverse Events | A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. | Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an Overall Resonse | Cetuximab | 8.2 | 95% Confidence Interval 3.4 to 16.2 | percentage of participants | |
| Percentage of Participants With Disease Control (CR, PR, or SD) | Cetuximab | 49.4 | 95% Confidence Interval 38.4 to 60.5 | Percentage of participants | |
| Duration of Response | Cetuximab | 5.1 | 95% Confidence Interval 2.7 to 6.9 | Months | |
| Time to Progression | Cetuximab | 2.5 | 95% Confidence Interval 1.3 to 2.8 | Months | |
| Overall Survival | Cetuximab | 10.0 | 95% Confidence Interval 7.5 to 12.0 | Months | |
| Number of Participants With Adverse Events | Cetuximab | 85 | Participants | ||
| Number of Participants With Serious Adverse Events | Cetuximab | 19 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetuximab | 85 | |
| Overall Study | COMPLETED | Cetuximab | 85 | |
| Overall Study | NOT COMPLETED | Cetuximab | 0 |
Source ClinicalTrials.gov
Adverse events45
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Cetuximab | 8 | 85 | 8 |
| other | Constipation | Gastrointestinal disorders | Cetuximab | 8 | 85 | 11 |
| other | Diarrhea | Gastrointestinal disorders | Cetuximab | 12 | 85 | 17 |
| other | Nausea | Gastrointestinal disorders | Cetuximab | 13 | 85 | 14 |
| other | Stomatitis | Gastrointestinal disorders | Cetuximab | 9 | 85 | 10 |
| other | Vomiting | Gastrointestinal disorders | Cetuximab | 8 | 85 | 11 |
| other | Chills | General disorders | Cetuximab | 6 | 85 | 8 |
| other | Fatigue | General disorders | Cetuximab | 27 | 85 | 33 |
| other | Oedema peripheral | General disorders | Cetuximab | 6 | 85 | 6 |
| other | Pyrexia | General disorders | Cetuximab | 6 | 85 | 6 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab | ||
| Total, other adverse events | Cetuximab | 84 | 85 |
| Total, serious adverse events | Cetuximab | 19 | 85 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00083720
GET https://conductscience.org/api/trials/v1/NCT00083720/events?page=2