Panitumumab and Bortezomib for Patients With Advanced Colorectal Cancer

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Panitumumab plus bortezomib for colon cancer

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Antibodies, Monoclonal; Bortezomib; Panitumumab

Criteria

Inclusion Criteria:

• 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 berange 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 Criteria:

• 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)