Panitumumab and Bortezomib for Patients With Advanced Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01504477|
Recruitment Status : Terminated (Low accrual--unable to meet accrual goals)
First Posted : January 5, 2012
Results First Posted : March 16, 2020
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Panitumumab and bortezomib||Phase 1 Phase 2|
This study is for patients with colon cancer that cannot be fully removed by surgery and has come back after or not responded to standard chemotherapy treatment.
Subjects will be enrolled to either the first part of the study (Phase I) or the second part of the study (Phase II). Phase I will be completed before Phase II will start. The purpose of the Phase I part is to find the highest dose of bortezomib that can be given with panitumumab without causing severe side effects. The purpose of the Phase II part is to test the effects the two drugs have on subjects with colorectal cancer.
Panitumumab is a drug that targets a protein important for the growth of cancer cells known as EGFR. By blocking the activity of the protein, panitumumab can block cancer cell growth and even lead to their death. Panitumumab is given intravenously once every two weeks. Panitumumab is approved by the FDA for patients with colorectal cancer.
Bortezomib is a drug that targets a part of the cancer cell known as the proteosome. By inhibiting the proteosome, bortezomib can inhibit cancer cell growth and even lead to their death. Bortezomib is given intravenously, once a week, 3 out of every 4 weeks. Bortezomib is not FDA approved for the treatment of colorectal cancer.
As part of this study the investigators will be taking biopsies of patients' tumors before any treatment, after starting with the panitumumab alone, and after receiving both the panitumumab and bortezomib. The investigators want to investigate what markers inside tumors may relate to how well these two medications work. These biopsies are required as part of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Clinical Trial of the Anti-EGFR Monoclonal Antibody, Panitumumab, and the Proteosomal Inhibitor, Bortezomib, in Patients With Advanced, Refractory KRAS Wild-Type Colorectal Cancer|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Combination of Panitumumab and Bortezomib
IV panitumumab and bortezomib
Drug: Panitumumab and bortezomib
Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle.
Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
- Maximum Tolerated Dose [ Time Frame: 12 months ]The maximum tolerated dose of bortezomib (to be used in combination with panitumumab)
- Maximum Tolerated Dose [ Time Frame: 12 months ]The maximum tolerated dose of panitumumab (to be used in combination with bortezomib)
- Percent of Patients With Disease Control [ Time Frame: 16 weeks ]Stable disease after 2 cycles, partial response or complete response as determined by RECIST v1.0
- Percent of of Patients With a Complete or Partial Response [ Time Frame: 16 weeks ]Partial response plus complete response as per RECIST v1.0
- Duration of Disease Control [ Time Frame: 2 years ]Time from study registration until progressive disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504477
|United States, District of Columbia|
|Georgetown Lombardi Comprehensive Cancer Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Michael Pishvaian, MD PhD||Georgetown University|