Clinical trial · Interventional
Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by Surgery
A Preoperative Biological Trial of Cetuximab, Dasatinib or the Combination in Colorectal Cancer Patients With Resectable Liver Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase 0 trial is studying whether 2 weeks of cetuximab and dasatinib will change tumor cells in patients with colorectal cancer and liver metastases that can be removed by surgery. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | — | UNRESOLVED | — |
| Mucinous Adenocarcinoma of the Colon | Colon Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Mucinous Adenocarcinoma of the Rectum | Rectal Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Signet Ring Adenocarcinoma of the Colon | — | UNRESOLVED | — |
| Signet Ring Adenocarcinoma of the Rectum | Rectal Signet Ring Cell Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort A (no systemic neoadjuvant therapy)
- description
- Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
- interventionNames
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Cohort B (cetuximab)
- description
- Patients receive 400 mg/m\^2 cetuximab IV over 120 minutes on day 1 and 250 mg/m\^2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15.
- interventionNames
- Biological: cetuximab
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed adenocarcinoma arising from the large intestine that has metastasized to the liver; liver metastases may be synchronous or metachronous * The liver metastases must be considered surgically resectable prior to the initiation of study drugs * Prior chemotherapy or chemoradiotherapy for colorectal cancer is allowed provided that toxicities from prior therapy have resolved to Grade 1 or less; no prior anti-EGFR or anti-Src therapy is allowed * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Absolute neutrophil count \>= 1.5 x 10\^9/L * Hemoglobin ≥ 9.0 Gm/dL * Platelets \>= 100 x 10\^9/L * Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) =\< 5 x institutional upper limit of normal * Creatinine =\< 1.5 institutional ULN * Women must have a negative pregnancy test; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document * Although KRAS status will be evaluated in the tumor, wild type KRAS status is not an eligibility criterion Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab or dasatinib * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cetuximab or dasatinib, breastfeeding should be discontinued if the mother is treated with cetuximab or dasatinib * Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with cetuximab or dasatinib; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated * Patients on potent CYP3A4 inducers and inhibitors
References
Publications (0)
Data not yet available