This phase II trial studies the side effects and how well niraparib and panitumumab work in treating patients with colorectal cancer that has spread to other places in the body. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as panitumumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and panitumumab may work better in treating patients with colorectal cancer.
PRIMARY OBJECTIVE: I. Evaluate the activity of the combination of niraparib with epidermal growth factor receptor (EGFR) inhibitor panitumumab in previously treated patients with rat sarcoma gene (RAS) wild type (WT) metastatic colorectal cancer. SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of niraparib and panitumumab. II. Evaluate the activity of the combination of niraparib and panitumumab in previously treated patients with metastatic colorectal cancer. OUTLINE: Patients receive niraparib orally (PO) once daily (QD) on days 1-28 and panitumumab intravenously (IV) over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 6 months for 2 years, and then annually for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Given PO
Given IV
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Clinical Benefit Rate (CBR)
The efficacy, as measured by clinical benefit rate (CBR), will be assessed for the total number of patients enrolled. CBR = (Complete Response + Partial Response + Stable Disease \[CR +PR + SD\] rate. Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review.
Time frame: 3 years and 7 months post treatment
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the percentage of patients with complete response (CR) or partial response (PR), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review.
Time frame: Up to 5 years post treatment
Duration of Response (DOR)
Duration of response (DOR) is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until the time of first documentation of disease progression, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review.
Time frame: Up to 5 years post treatment
Progression Free Survival (PFS)
For progression free survival (PFS), progression or death from any cause will be defined as the event. Progression will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review. Patients will be censored at time of last follow-up.
Time frame: Up to 5 years post treatment
Overall Survival (OS)
For overall survival (OS), death from any cause will be defined as the event. Patients will be censored at time of last follow-up.
Time frame: Up to 5 years post treatment
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