This phase I trial studies the side effects and best dose of oxaliplatin when given together with capecitabine and bevacizumab in treating patients with peritoneal cancer from previously treated cancer of the colon, rectum, or appendix. Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Infusing oxaliplatin directly into the abdomen may kill more tumor cells while reducing side effects. Monoclonal antibodies, such as bevacizumab, can block tumor growth by stopping the formation of blood vessels that feed them. Giving oxaliplatin directly into the abdomen, in addition to treatment with and capecitabine and bevacizumab may be effective in patients with peritoneal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT01061515.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES
I. To determine the maximum tolerated dose of intraperitoneal (IP) oxaliplatin with systemic intravenous bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan documenting function intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology.
II. To assess the safety and tolerability of repeated delayed intraperitoneal chemotherapy with oxaliplatin and systemic intravenous bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan documenting function intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology.
III. To describe the progression rate, progression-free survival and overall survival in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of oxaliplatin.
Patients receive oxaliplatin IP over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice daily (BID) on days 1-7. Treatment repeats every 14 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up annually.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorBenjamin R. Tan