Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients

Launched by FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI, MILANO · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a combination treatment of two medications, capecitabine and cyclophosphamide, for patients with a type of cancer called Pseudomyxoma Peritonei (PMP). Specifically, it focuses on patients with a more severe form of this condition, indicated by a peritoneal cancer index score greater than 28. Participants will take these medications in low doses over six months before undergoing standard treatment, which includes surgery to remove the cancer and a procedure known as hyperthermic intraperitoneal chemotherapy (HIPEC). The main goal is to find out how many patients achieve complete removal of the cancer during surgery after receiving this treatment.

To be eligible for this trial, patients must be adults aged between 18 and 75 years with a confirmed diagnosis of PMP and a specific level of disease severity. They should have good overall health and organ function and will need to be able to attend follow-up visits. It's important for potential participants to understand that they cannot have had previous treatments for cancer or other serious health issues that might complicate their participation. If you or someone you know is considering joining this study, it’s a great opportunity to contribute to a better understanding of treatment options for this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical/Histological diagnosis of pseudomyxoma peritonei (PMP);
• • Peritoneal Cancer Index (PCI \>28) assessed by chest and abdominal CT scan at the staging phase;
• • Age \>= 18 years and \<76 years;
• • Performance Status (ECOG \<2);
• * Adequate organ function including the following:
• • Adequate bone marrow reserve: WBC count \>3.0x109/L, absolute neutrophyl count \>1.5x109/L, platelet count \>100x109/L, and hemoglobin \>10 g/dL;
• • Hepatic: bilirubin \< 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase \< 2.5 x UL;
• • Renal: Creatinine clearance \>50 mL/min or serum creatinine \<1.5 x UNL;
• • Patients compliance and geographic proximity that allows for adequate follow-up;
• • Patients must sign an informed consent document (ICD);
• • Male and female patients with reproductive potential must use an approved contraceptive method;
• Exclusion Criteria:
• • Peritoneal Cancer Index (PCI ≤28) assessed by chest and abdominal CT scan at the staging phase;
• • DPD deficiency;
• • Previous systemic chemotherapy and/or biological therapy;
• • Administration of other experimental drugs during the study Pregnancy and breast-feeding;
• • Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment;
• • Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis;
• • Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures;
• • Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years.