New Individualized Therapy Trial for Metastatic Colorectal Cancer (NITMEC)
|ClinicalTrials.gov Identifier: NCT00867334|
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : March 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasm Colorectal Cancer||Drug: Imatinib mesylate followed by a combination of imatinib mesylate & panitumumab Drug: Standard-of-care treatment with panitumumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Gleevec® Combined With Panitumumab (Vectibix®) in Patients Prescreened for C-kit/PDGFr Activated Pathways Using a Proteomic Based Assay|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.
Drug: Imatinib mesylate followed by a combination of imatinib mesylate & panitumumab
Patients will be entered into sequential cohorts with escalating doses of imatinib mesylate. After approximately 28 days of monotherapy treatment with imatinib mesylate, patients will be asked to have a liver biopsy performed (this biopsy is voluntary and is not required for continued participation in the study). All patients in this group will then receive imatinib mesylate in combination with standard-of-care doses of panitumumab. After approximately 1-2 months of combination treatment, patients will asked to have an additional liver biopsy performed (this biopsy is voluntary and is not required for continued participation in the study). Combination treatment will continue for the remainder of the subject's time in the trial.
Active Comparator: 2
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 2. Participants in Arm 2 will receive standard-of-care treatment with panitumumab.
Drug: Standard-of-care treatment with panitumumab
Panitumumab as standard of care. After approximately 2-3 months of standard of care treatment, patients will asked to have a liver biopsy performed (this biopsy is voluntary and is not required for continued participation in the study).
- Assess the safety and tolerability of the combination imatinib mesylate and panitumumab in this population. [ Time Frame: Continually ]
- Stabilization or reduction in tumor size by imaging of the hepatic metastasis. [ Time Frame: Every 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867334
|United States, Virginia|
|Virginia Cancer Specialists, PC|
|Fairfax, Virginia, United States, 22031|
|Inova Fairfax Hospital Department of Surgery|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Kirsten Edmiston, MD, FACS||Inova Fairfax Hospital Cancer Center|