Status:
TERMINATED
Panitumumab and Bortezomib for Patients With Advanced Colorectal Cancer
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Panitumumab plus bortezomib for colon cancer
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- Histologically proven colorectal cancer with measurable or evaluable disease
- KRAS wild-type colorectal cancer
- Progression on, or intolerance of, or ineligibility for all standard therapies
- Progression on prior anti-EGFR therapy
- Lesion that is amenable to biopsy
- ECOG performance status 0-2
- LVEF \>/= institutional normal
- Corrected QT interval less then 500 milliseconds by EKG
- Grade 2 or less peripheral neuropathy
- Adequate hepatic, bone marrow, and renal function
- Partial thromboplastin time must be \</= 1.5 x upper limit of institution's normal range and INR \< 1.5. Subjects on anticoagulants will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator.
- Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease and have not had treatment with steroids within 1 week of study enrollment.
- Life expectancy \> 12 weeks
- Subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent form.
Exclusion
- CNS metastases which do not meet the criteria above
- Prior cancer chemotherapy, radiation therapy, or any investigational agent within three weeks before starting therapy
- Active severe infection or known chronic infection with HIV or hepatitis B virus
- Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
- Peripheral neuropathy \>/= Grade 2 at baseline or peripheral neuropathy \>/= Grade 1 with neuropathic pain
- Life-threatening visceral disease or other severe concurrent disease
- Female subject is pregnant or lactating
- Diagnosed or treated for another malignancy within 3 years of enrollment with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
- Patient has hypersensitivity to bortezomib, boron, or mannitol
- Clinically significant and uncontrolled major medical condition(s)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01504477
Start Date
December 1 2011
End Date
February 1 2014
Last Update
March 16 2020
Active Locations (1)
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1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007