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| Sponsor: | Vanderbilt-Ingram Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00835679 |
Purpose
RATIONALE: 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. Giving cetuximab and/or dasatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This early phase I trial is studying how well cetuximab and/or dasatinib works in treating patients with colorectal cancer and liver metastases that can be removed by surgery.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer Metastatic Cancer |
Biological: cetuximab Drug: dasatinib Procedure: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Preoperative Biological Trial of Cetuximab, Dasatinib or the Combination in Colorectal Cancer Patients With Resectable Liver Metastases |
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Cohort A
Patients receive no systemic neoadjuvant therapy between the time of diagnostic biopsy and definitive surgical resection of liver metastases.
|
Procedure: therapeutic conventional surgery
definitive surgical resection of liver metastases
|
|
Experimental: Cohort B
Patients receive cetuximab IV over 60-120 minutes on days 1 and 8.
|
Biological: cetuximab
Given IV
Procedure: therapeutic conventional surgery
definitive surgical resection of liver metastases
|
|
Experimental: Cohort C
Patients receive oral dasatinib once daily on days 1-14.
|
Drug: dasatinib
Given orally
Procedure: therapeutic conventional surgery
definitive surgical resection of liver metastases
|
|
Experimental: Cohort D
Patients receive cetuximab IV over 60-120 minutes on days 1 and 8 and oral dasatinib once daily on days 1-14.
|
Biological: cetuximab
Given IV
Drug: dasatinib
Given orally
Procedure: therapeutic conventional surgery
definitive surgical resection of liver metastases
|
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are initially enrolled in cohort A. Once cohort A is completed, additional patients are enrolled and randomized to treatment in either cohorts B or C. If a significant biological effect is seen in cohorts B or C, additional patients are enrolled in cohort D.
All patients undergo definitive surgical resection of liver metastases on day 15.
Patients undergo tumor tissue (from initial liver tumor biopsies and liver resection samples), serum, and peripheral blood mononuclear cell sample collection periodically for biomarker analysis via IHC.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients must have organ and marrow function within the parameter defined below:
Exclusion Criteria
Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.
Contacts and Locations| United States, Florida | |
| Moffitt Cancer Center | Active, not recruiting |
| Tampa, Florida, United States, 33612 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Clinical Trials Information Program 800-811-8480 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| Principal Investigator: | Emily Chan, MD, Ph.D. | Vanderbilt-Ingram Cancer Center |
More Information
| Responsible Party: | Emily Chan, M.D., Ph.D., Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00835679 History of Changes |
| Other Study ID Numbers: | VICC GI 0838, P30CA068485, VU-VICC-GI-0838, 081338, 8069 |
| Study First Received: | February 3, 2009 |
| Last Updated: | July 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer adenocarcinoma of the rectum |
recurrent rectal cancer stage IV rectal cancer liver metastases |
|
Colorectal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Liver Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Neoplastic Processes Pathologic Processes Liver Diseases Cetuximab Dasatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |