Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title: Safety of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Biliary Tract Cancer Patients With Peritoneal Metastases

Status Recruiting

Clinical Trial Summary

This phase I trial studies the side effects of pressurized intraperitoneal aerosolized chemotherapy (PIPAC) nab-paclitaxel in combination with gemcitabine and cisplatin in treating patients with biliary tract cancer that has spread to the peritoneum (peritoneal metastases). PIPAC involves the administration of intraperitoneal chemotherapy (anticancer drugs given directly to the lining of the abdomen). PIPAC uses a nebulizer (a device that turns liquids into a fine mist) which is connected to a high-pressure injector and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and insert a camera and other instruments into the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen), which results in the drug reaching more of the tissue as well as reaching deeper into the tissue, which reduces the amount of chemotherapy that needs to be used and potentially reduces side effect. Chemotherapy drugs, such as nab-paclitaxel, gemcitabine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nab-paclitaxel via PIPAC in combination with standard of care gemcitabine and cisplatin may reduce side effects and make this chemotherapy regimen more tolerable in patients with biliary tract cancer that has spread to the spread to the peritoneum.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. Evaluate the safety of PIPAC nab-paclitaxel in combination with systemic chemotherapy in patients with biliary tract cancer with peritoneal metastases, based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

SECONDARY OBJECTIVES:

I. Efficacy. II. Post-operative surgical complications by Clavien-Dindo classification evaluated at 4 weeks after each PIPAC.

III. Median overall survival and median progression-free survival. IV. PIPAC technical failure rate. V. Patient-reported health state/quality of life and symptoms before treatment (week 1) and at weeks 7, 13, 19, and 25/off study, as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) and MD Anderson Symptom Inventory (MDASI).

VI. Functional status, as measured by the number of daily steps before and after treatments (Vivofit 4 wristband pedometer - Garmin Company).

EXPLORATORY OBJECTIVES:

I. Characterization of sub-clonal evolution and tumor microenvironment in response to therapy with a particular focus on immune subsets.

II. Pharmacokinetic and pharmacodynamic evaluations to evaluate the therapeutic advantage of PIPAC nab-paclitaxel delivery.

OUTLINE:

Patients receive gemcitabine intravenously (IV) over 30 minutes and cisplatin IV over 60 minutes on days 1 and 8. Patients also receive nab-paclitaxel via PIPAC over 5-10 minutes on day 3 of cycles 1, 3, and 5. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter. ;

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Biliary Tract Neoplasms
• Carcinoma, Ductal
• Cholangiocarcinoma
• Gallbladder Carcinoma
• Gallbladder Neoplasms
• Intrahepatic Cholangiocarcinoma
• Metastatic Malignant Neoplasm in the Peritoneum
• Stage IV Distal Bile Duct Cancer AJCC v8
• Stage IV Intrahepatic Bile Duct Cancer AJCC v8
• Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
• Stage IVB Gallbladder Cancer AJCC v8

• NCT number: NCT05285358
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Recruiting
• Phase: Phase 1
• Start date: September 19, 2022
• Completion date: October 11, 2028