Niraparib and Panitumumab in Treating Patients with Advanced or Metastatic Colorectal Cancer
18 Years and older, Male and Female
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. Panitumumab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Giving niraparib and panitumumab may work better in treating patients with colorectal cancer.
I. Evaluate the activity of the combination of niraparib with epidermal growth factor receptor (EGFR) Inhibitor panitumumab in previously treated patients with RAS WT metastatic colorectal cancer.
I. Define the toxicity profile of the combination of niraparib and panitumumab. The additional patients enrolled on the expansion cohorts will help confirm the toxicity profile.
II. Evaluate the activity of the combination of niraparib and panitumumab in previously treated patients with metastatic colorectal cancer.
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.
- Participant must have advanced, metastatic RAS wildtype colorectal cancer and must have received at least one line of palliative systemic therapy. Both microsatellite (MSI-H) high and stable (MSS) patients are eligible
- Participants may have been intolerant of, progressed on, or failed at least one line of systemic chemotherapy in the metastatic setting. Patients who are currently on first line Oxaliplatin-containing chemotherapy regimen are allowed on the trial if they have remained stable or better ([partial response]PR or [complete response]CR) for at least 4 months on that line of treatment and are being considered for maintenance therapy as standard of care
- Histologic or cytologic diagnosis of colorectal cancer
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
- Participant must be >= 18 years of age
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Hemoglobin >= 9 g/dL
- Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation
- Total bilirubin =< 1.5 x ULN (=< 2.0 in patients with known Gilberts syndrome) OR direct bilirubin =< 1 x ULN
- Aspartate aminotransferase and alanine aminotransferase =< 2.5 x ULN unless liver metastases are present, in which case they must be =< 5 x ULN
- Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy
- Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment
- Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment or is of nonchildbearing potential. Nonchildbearing potential is defined as follows (by other than medical reasons):
* >= 45 years of age and has not had menses for > 1 year
* Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound/screening computed tomography (CT)/magnetic resonance imaging (MRI) scans. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment
** Note: Abstinence is acceptable if this is the established and preferred contraception for the patient
- Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment
- Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 180 days after the last dose of study treatment
* Note: Abstinence is acceptable if this is the established and preferred contraception for the patient
- Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials