Trial · NCT00835679
Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by Surgery
NCT00835679, Early phase 1, Terminated, National Cancer Institute (NCI); results first posted 2012-09-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by Surgery. Trials, record NCT00835679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00835679
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by Surgery
- NCT number
- NCT00835679
- Status
- Terminated
- Phases
- Early phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Liver Metastases, Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IV Colon Cancer, Stage IV Rectal Cancer
- Interventions
- cetuximab, dasatinib, therapeutic conventional surgery, laboratory biomarker analysis
- First posted
- 2009-02-04
- Last updated
- 2014-05-23
- Results first posted
- 2012-09-07
- Limitations and caveats
Due to study design and slow accrual, no drug was received, no biomarkers were determined and no data obtained. 0 data is entered in the outcomes measures database as suggested by CT.gov previously. Detailed explanations are given.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients With a Biologic Response | on baseline and preoperatively on day of surgery (day 15) | Patients who experienced a pre-to-post treatment reduction of at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker of the pathway being inhibited: epidermal growth factor (EGFR) for Cohort B, sarcoma (Src) for Cohort C, and both EGFR and Src for Cohort D. Blood for these biomarkers will be taken on day of baseline and pre-operatively on day 15. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for pathway in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%). |
| Secondary | Patients With Reduction of Biomarkers in Tumor Tissue | study entry to day 15 | Patients with pre-to-post treatment reduction at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker: total \& phi-EGFR, phi-MAPK, phi-Akt, Ki67, phi-FAK, phi-paxillin, phi-Src, capase 3. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for biomarker in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%) |
| Secondary | Number of Patients With the Given Severity of Adverse Event Within a Specified Duration | weekly to day 15, and at followup on day 30 | Number of patients with each grade of adverse event (AE) during the specified timeframe using the Common Terminology Criteria for AEs guide, grades 1-5 with one being mild, five is death. |
| Secondary | Number of Patients With the Given Severity of Post-operative Complications Within the Specified Duration | From day 15 (day of surgery) to 30 days after surgery |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patients With a Biologic Response | on baseline and preoperatively on day of surgery (day 15) | No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual. | ||
| SECONDARY | Patients With Reduction of Biomarkers in Tumor Tissue | study entry to day 15 | No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual. | ||
| SECONDARY | Number of Patients With the Given Severity of Adverse Event Within a Specified Duration | weekly to day 15, and at followup on day 30 | No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No patients were accrued to Cohorts B, C, D. This study was closed prematurely due to slow accrual. | ||
| SECONDARY | Number of Patients With the Given Severity of Post-operative Complications Within the Specified Duration | From day 15 (day of surgery) to 30 days after surgery | No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers.No patients received any study drugs. This study was closed prematurely due to slow accrual. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | No Treatment Cohort A | 9 | |
| Overall Study | STARTED | Cetuximab Cohort B | 0 | |
| Overall Study | STARTED | Dasatinib Cohort C | 0 | |
| Overall Study | STARTED | Cetuximab + Dasatiib Cohort D | 0 | |
| Overall Study | COMPLETED | No Treatment Cohort A | 8 | |
| Overall Study | COMPLETED | Cetuximab Cohort B | 0 | |
| Overall Study | COMPLETED | Dasatinib Cohort C | 0 | |
| Overall Study | COMPLETED | Cetuximab + Dasatiib Cohort D | 0 | |
| Overall Study | NOT COMPLETED | No Treatment Cohort A | 1 | |
| Overall Study | NOT COMPLETED | Cetuximab Cohort B | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | No Treatment Cohort A | ||
| Total, all-cause mortality | Cetuximab Cohort B | ||
| Total, all-cause mortality | Dasatinib Cohort C | ||
| Total, all-cause mortality | Cetuximab + Dasatiib Cohort D | ||
| Total, other adverse events | No Treatment Cohort A | 0 | 9 |
| Total, other adverse events | Cetuximab Cohort B | 0 | 0 |
| Total, other adverse events | Dasatinib Cohort C | 0 | 0 |
| Total, other adverse events | Cetuximab + Dasatiib Cohort D | 0 | 0 |
| Total, serious adverse events | No Treatment Cohort A | 0 | 9 |
| Total, serious adverse events | Cetuximab Cohort B | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA068485 | Cancer Center Support Grant | PARK, BEN HO | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL CANCER INSTITUTE | 1995 to 2025 |
Source NIH RePORTER
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/NCT00835679
GET https://conductscience.org/api/trials/v1/NCT00835679/registered