Panitumumab and Bortezomib for Patients With Advanced Colorectal Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Colorectal Cancer

In brief

Panitumumab plus bortezomib for colon cancer

Key facts

Study ID

NCT01504477

Run by

Georgetown University

People needed

6

Starts

2011-12-01

Expected to finish

2014-02-01

Last updated by the study team

2020-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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