RecruitingPhase 2NCT06800391

Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients

Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in Huge (PCI>28) Pseudomyxoma Peritonei Patients Candidates to Cytoreductive Surgery (CRS) and Hypertermic Intraperitoneal Chemotherapy (HIPEC)

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

31 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

Pseudomyxoma Peritonei

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant capecitabine and cyclophosphamide treatment in patients affected by huge Pseudomyxoma peritonei (PMP) (peritoneal cancer index \>28). Treatment consists of metronomic (low-dose medication for a prolonged time) of capecitabine plus cyclophosphamide for 6 months followed by standard of care cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The main question the trial aims to answer is which is the proportion of patients with complete cytoreduction at CRS/HIPEC after neoadjuvant metronomic approach with oral capecitabine and cyclophosphamide in patients affected by huge PMP.

Eligibility

Min Age: 18 YearsMax Age: 76 Years

Inclusion Criteria11

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 Criteria8

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.

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Interventions

COMBINATION_PRODUCTCapecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day

Capecitabine (1250 mg/m2 /day) and Cyclophosphamide (50 mg/day) continuous daily dosing. Cycles are to be repeated every 28 days for a total of 6 cycles.