Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients

NCT05321329 | Unknown Phase 2 DMC

• 1 other identifier: INT 36/18
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pseudomyxoma Peritonei

Outcome Measures

Primary Outcomes (1)

• PFS

  To evaluate the efficacy of postoperative capecitabine in terms of progression free survival (PFS) after CRS and HIPEC in patients with KRAS mutated PMP with extensive peritoneal disease

  Progression free survival is time between treatment start date and first date of recurrence or death, whichever occurs first.

Secondary Outcomes (2)

• OS

  Overall survival (OS) is time between the date of chemotherapy start and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive

• DSS

  Disease Specific Survival (DSS) is time between the date of chemotherapy start and the date of death caused by cancer. Deaths from other causes are not "events".

Study Arms (1)

Single Arm

EXPERIMENTAL

Capecitabine will be taken orally at dose of 1250 mg/m2 PO BID on days 1→14 every 3 weeks Cycles are to be repeated every 21 days for a total of 8 cycles

Drug: Capecitabine

Interventions

Capecitabine DRUG

Capecitabine is a deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.Capecitabine is a Nucleoside Metabolic Inhibitor. The mechanism of action of capecitabine is as a Nucleic Acid Synthesis Inhibitor.

Single Arm

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, MI, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Pseudomyxoma Peritonei

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Maria Di Bartolomeo, MD

  IRCCS Istituto Nazionale Tumori MIlano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shigeki Kusamura, MD PhD

CONTACT

02/23902362; shigeki.kusamura@istitutotumori.mi.it

Maria Di Bartolomeo, MD

CONTACT

02/23902882; maria.dibartolomeo@istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, non-comparative study

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 11, 2022
• Study Start: December 3, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 11, 2022

Record last verified: 2022-03

Locations

IT (1)