Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, mono institutional, non comparative study, evaluating adjuvant capecitabine in patients affected by KRAS mutated Pseudomyxoma peritonei treated with cytoreductive surgery and HIPEC.

Patient will be treated with 8 cycles of the study regimen that include:

Capecitabine 1250 mg/m2 PO BID day 1-14 q21 days

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Patients submitted to a complete cytoreductive surgery and subsequent HIPEC for PMP

• Histological diagnosis of pseudomyxoma peritonei (PMP)

• Assessment of KRAS mutation positivity on surgical sample

• 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 xULN

• 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:

• 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