Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases

NCT05371223 | Recruiting Phase 2

• 1 other identifier: 4368
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Combined chemotherapy consisting of endovenous Nabpaclitaxel-Gemcitabine and Nabpaclitaxel-PIPAC may be a promising treatment for patients affected by pancreatic cancer PM who are in need of curative options. The purpose of this study is to evaluate the antitumoral activity of combined Nabpaclitaxel-PIPAC and systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases. Secondary objectives include the evaluation of the feasibility, the safety, further assessment of the antitumoral activity, the overall and progression free survival, the QoL, the pharmacokinetics of Nabpaclitaxel PIPAC. Furthermore, the study aims to evaluate the patients' nutritional status and the molecular evolution of PM along treatment with a time-course translational research.

Conditions

Peritoneal Carcinomatosis; Pancreas Neoplasm

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  The Disease Control Rate (DCR) defined as the combined incidence of complete response (CR), partial response (PR) and stable disease (SD) according to the RECIST v. 1.1 criteria during study treatments and the EOT visit.

  Three and a half years

Secondary Outcomes (9)

• The compliance to treatment

  Three and a half years

• Toxicity assessed by CTCAE

  Three and a half years

• Postoperative complication assessed by Clavien-Dindo

  Three and a half years

• Antitumoral activity assessed by PRGS

  Three and a half years

• Antitumoral activity assessed by PCI

  Three and a half years

Other Outcomes (3)

• The intravenous area under the curve (AUC) of paclitaxel

  Three and a half years

• Intra-patient e intra-tumoral heterogeneity

  Three and a half years

• Identification of pancreatic cancer disease evolution trough pathway analysis a in primary tumor and peritoneal sites during treatments

  Three and a half years

Study Arms (1)

Interventional

EXPERIMENTAL

Eligible patients affected by pancreatic cancer PM will be enrolled according to in-/exclusion criteria. Each patient will be scheduled for three treatment combined courses for a total of six cycles of endovenous Nabpaclitaxel-Gemcitabine chemotherapy and three of Nabpaclitaxel-PIPAC.

Drug: Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine

Interventions

Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine DRUG

Each combined course is constituted by two consecutive 28-day cycles of systemic chemotherapy (three adminstrations per cycle: days 1,8 and 15) and one cycle of PIPAC administered within 10-13 days from the last administration of systemic chemotherapy. Between each combined course a 7-10 days pause is observed. The recommended dose of Nabpaclitaxel in combination with Gemcitabine is 125 mg/m2 administered endovenous over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. The concurrent recommended dose of Gemcitabine is 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of Nabpaclitaxel administration on Days 1, 8 and 15 of each 28-day cycle. A pressurized aerosol containing Nabpaclitaxel at the dose of 112,5 mg/m2 diluted in a total volume of 200 ml of NaCl 0.9% is applied through the nebulizer inside the abdominal cavity during laparoscopy.

Interventional

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years;
• Willing and able to provide written and informed consent;
• Histological or cytological proof of pancreatic cancer;
• Metastatic disease with peritoneal carcinomatosis determined by the treating physician, based on abdominal CT or MR and/or diagnostic laparotomy or laparoscopy;
• Evaluable disease defined by RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• Life expectancy of at least 3 months;
• No contraindication for laparoscopy;
• No contraindication for drugs used in the study;
• Adequate bone marrow function: Absolute neutrophil count ≥ 1500 cell./mm3; Platelets ≥ 100000 cell./mm3;
• Hemoglobin ≥ 9 g/dl
• Adequate renal function (serum creatinine up to 1.5 times the maximal limit of the local laboratory) or else based upon clinical evaluation;

You may not qualify if:

• Advanced metastatic systemic disease with clinical deterioration;
• Patients with extraabdominal tumor spread;
• Patients with a germline or somatic pathogenic variant involving an (Homologous Recombination Repair) HRR-related gene;
• Symptoms of gastrointestinal occlusion and total parenteral nutritional support;
• Patients defined as "refractory" to previous systemic treatment with Nab-paclitaxel and Gemcitabine administered for locally advanced pancreatic cancer (patients treated with Nabpaclitaxel-Gemcitabine for a locally advanced disease may be included if PM developed after at least 6 months from the end of previous chemotherapy);
• History of severe and unexpected reactions to Nabpaclitaxel or Gemcitabine derivates
• Known hypersensitivity reaction to drugs chemically related to Nabpaclitaxel, Gemcitabine and their excipients;
• Severe cardiac disease (recent myocardial ischemia, severe cardiac arrhythmias, severe cardiac failure);
• Clinical disease progression after first 2 months of systemic Nabpaclitaxel Gemcitabine chemotherapy;
• Any concurrent severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of associated with study participation or investigational product administration or may interfere with compliance with study procedures or the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into the study;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Related Publications (1)

• Di Giorgio A, Ferracci F, Bagala C, Carbone C, Salvatore L, Strippoli A, Attalla El Halabieh M, Abatini C, Alfieri S, Pacelli F, Tortora G. Combined Nabpaclitaxel pressurized intraPeritoneal aerosol chemotherapy with systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases: protocol of single-arm, open-label, phase II trial (Nab-PIPAC trial). Pleura Peritoneum. 2024 Nov 6;9(3):121-129. doi: 10.1515/pp-2024-0010. eCollection 2024 Sep.

  PMID: 39544430 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Andrea Di Giorgio, MD

  UOS trattamenti integrati della carcinosi peritoneale avanzata -UOC Chirurgia del peritoneo e retroperitoneo - Fondazione Policlinico Universitario A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Di Giorgio, MD

CONTACT

+393288994872; andrea.digiorgio@policlinicogemelli.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

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: May 12, 2022
• Study Start: March 1, 2022
• Primary Completion: May 30, 2025
• Study Completion: July 30, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)