Gallbladder Cancer > Cisplatin

Aerosolized Chemotherapy for Biliary Tract Cancer

Recruiting in Palo Alto (17 mi)

Overseen By Mustafa Raoof, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies a new way to deliver chemotherapy directly into the abdomen as a fine mist for patients with biliary tract cancer that has spread. The goal is to see if this method, combined with standard chemotherapy, is safe and more tolerable. The fine mist helps the drugs reach more tissue and may reduce side effects. Gemcitabine, often combined with cisplatin, is a standard chemotherapy for advanced biliary tract cancer.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot take strong CYP3A4 inducers/inhibitors or therapeutic antibiotics within 14 days before starting the trial. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of this treatment for biliary tract cancer?

Research suggests that using pressurized intraperitoneal aerosol chemotherapy (PIPAC) with nanoparticle albumin-bound paclitaxel (nab-Paclitaxel) may be effective for treating peritoneal metastases, as it has shown promise in other cancers like pancreatic and ovarian cancer. Additionally, nab-Paclitaxel combined with gemcitabine has been effective in treating advanced pancreatic cancer, which shares some characteristics with biliary tract cancer.

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Is aerosolized chemotherapy with nab-paclitaxel safe for humans?

Research shows that nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has been studied for safety in humans, including in treatments for various cancers like breast, lung, and pancreatic cancer. It is generally considered safe and is approved for use in several countries, with studies indicating it avoids some toxicities associated with other formulations.

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How is the treatment for biliary tract cancer using PIPAC with Cisplatin, Gemcitabine, and Nab-paclitaxel different from other treatments?

This treatment is unique because it uses pressurized intraperitoneal aerosol chemotherapy (PIPAC), which delivers chemotherapy directly into the abdominal cavity as a spray, potentially increasing drug exposure to cancer cells in the peritoneum (the lining of the abdominal cavity) compared to traditional methods.

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Eligibility Criteria

This trial is for adults with biliary tract cancer that has spread to the lining of their abdomen. They must have certain blood counts, liver and kidney function, no HIV or controlled hepatitis, and not be pregnant. They can't join if they've had other cancers (except some skin cancers), brain metastases, severe uncontrolled illnesses, significant neuropathy, or recent strong drug interactions.

Inclusion Criteria

My cancer has spread to the lining of my abdomen and can be seen on scans.

My kidney function, measured by creatinine clearance, is adequate.

I am 18 years old or older.

I have recovered from the side effects of my previous cancer treatment.

My cancer is confirmed to be in the bile ducts or gallbladder.

I am fully active or can carry out light work.

Exclusion Criteria

I have received treatment for advanced bile duct or gallbladder cancer.

I have had treatments for a blocked intestine.

I have a history of cancer.

Half of my liver is affected by cancer spread.

I do not have any uncontrolled serious illnesses.

I have had, or currently have, cancer spread to my brain.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

Participant Groups

The trial tests a new way to deliver chemotherapy called PIPAC with nab-paclitaxel combined with gemcitabine and cisplatin in patients whose biliary tract cancer has spread within the abdomen. It aims to see if this method reduces side effects while effectively treating the cancer.

Group I: Treatment (gemcitabine, cisplatin, nab-paclitaxel PIPAC) Experimental Treatment 5 Interventions

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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

🇺🇸 Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

🇨🇦 Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

🇯🇵 Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Find A Clinic Near You

Research locations nearby Select from list below to view details:

City of Hope Medical Center Duarte, CA

Who is running the clinical trial?

City of Hope Medical Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. Germany pubmed.ncbi.nlm.nih.gov

Intraperitoneal aerosolization of albumin-stabilized paclitaxel nanoparticles (Abraxane™) for peritoneal carcinomatosis - a phase I first-in-human study. [2023] Nanoparticles hold considerable promise for aerosol-based intraperitoneal delivery in patients with carcinomatosis. Recently, results from preclinical and early clinical trials suggested that albumin-bound paclitaxel (ABP, Abraxane™) may result in superior efficacy in the treatment of peritoneal metastases (PM) compared to the standard solvent-based paclitaxel formulation (Taxol™). Here, we propose a phase I study of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using ABP in patients with upper Gastrointestinal, breast, or ovarian cancer.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Phase I study of intraperitoneal aerosolized nanoparticle albumin based paclitaxel (NAB-PTX) for unresectable peritoneal metastases. [2022] Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a novel method to treat patients with peritoneal metastases (PM). We aimed to study the tolerability, safety, pharmacokinetics, and tumour response of nanoparticle albumin bound paclitaxel (NAB-PTX) during PIPAC in a Phase I study.

3. Greece pubmed.ncbi.nlm.nih.gov

First Clinical Data of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) as Salvage Therapy for Peritoneal Metastatic Biliary Tract Cancer. [2022] Patients suffering from peritoneal metastasis of biliary tract cancer were treated with pressurized intraperitoneal aerosol chemotherapy (PIPAC).

4. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. [2022] Treatment of patients with advanced pancreatic carcinoma (APC) and hyperbilirubinaemia is problematic because these patients were regularly excluded from clinical studies. Nanoparticle albumin-bound paclitaxel and gemcitabine (nab-P/G) is an evidence-based treatment for patients with APC. This retrospective study investigated the safety and efficacy of nab-P/G in patients with APC and cholestatic hyperbilirubinaemia.

5. England pubmed.ncbi.nlm.nih.gov

Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin or oxaliplatin for peritoneal metastasis from pancreatic adenocarcinoma and cholangiocarcinoma. [2022] Systemic chemotherapy for pancreatic adenocarcinoma (PDAC) and cholangiocarcinoma (CC) with peritoneal metastases (PM) is affected by several pharmacological shortcomings and low clinical efficacy. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is expected to maximize exposure of peritoneal nodules to antiblastic agents. This study aims to evaluate safety and efficacy of PIPAC for PM of PDAC and CC origin.

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy evaluation of albumin-bound paclitaxel. [2015] Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel solvent-free formulation of paclitaxel, which was developed to avoid toxicities associated with Cremophor EL® vehicle used in solvent-based paclitaxel. It is approved as monotherapy for treatment of metastatic breast cancer (MBC) in Europe and the US; in combination therapy for non-small-cell lung cancer (NSCLC) and for first-line treatment of advanced pancreatic cancer (PC) only in the US. The European Medicines Agency has recently released only a positive opinion for use of nab-paclitaxel in PC.

7. England pubmed.ncbi.nlm.nih.gov

A phase II study of nab-paclitaxel in combination with ramucirumab in patients with previously treated advanced gastric cancer. [2023] Nanoparticle albumin-bound (nab)-paclitaxel was developed to improve paclitaxel solubility and does not need premedication to avoid infusion-related reactions associated with solvent-based (sb)-paclitaxel. We conducted a phase II trial to investigate the efficacy and safety of nab-paclitaxel plus ramucirumab combination therapy for previously treated advanced gastric cancer.