Neoplasms

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Digestive System Diseases

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Carcinoma

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Carcinoma, Ductal

Biliary Tract Neoplasms

Gallbladder Neoplasms

Bile Duct Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

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Biliary Tract Diseases

Gastrointestinal Diseases

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Bile Duct Diseases

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Biliary Tract Cancer

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Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Patients receive gemcitabine 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.

Nab-paclitaxel

Quality-of-Life Assessment

Questionnaire Administration

Daneng Li, MD

Mustafa Raoof, MD

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.

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.

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

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

Measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities observed during the first 6 weeks after the first cycle will be summarized by type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment, and reversibility or outcome.

Measured by Response Evaluation Criteria in Solid Tumors (RECIST) via computerized tomography (CT) scan.

Measured by Peritoneal Regression Grading Score (PGRS) via biopsy at each Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) cycle.

Measured by Peritoneal Carcinomatosis Index (PCI) at the time of laproscopy.

Measured by Clavien-Dindo classification. Results will be strictly descriptive in nature.

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Will be described using the Kaplan-Meier method.

Measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire and MD Anderson Symptom Inventory.

Measured by the number of daily steps before and after treatments (Vivofit 4 wristband pedometer - Garmin Company).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases	NCT05285358	Distal Bile Duc... Gallbladder Car... Intrahepatic Ch... Metastatic Mali... Stage IV Distal... Stage IV Intrah... Stage IV Intrah... Stage IVB Gallb...	Cisplatin Gemcitabine Nab-paclitaxel Quality-of-Life... Questionnaire A...	18 Years -	City of Hope Medical Center
Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases	NCT05285358	Distal Bile Duc... Gallbladder Car... Intrahepatic Ch... Metastatic Mali... Stage IV Distal... Stage IV Intrah... Stage IV Intrah... Stage IVB Gallb...	Cisplatin Gemcitabine Nab-paclitaxel Quality-of-Life... Questionnaire A...	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for distal bile duct adenocarcinoma