What side effects are associated with this type of intervention?

Common treatments for bile duct cancer, such as nab-paclitaxel, gemcitabine, and cisplatin, are associated with several side effects. Nab-paclitaxel and gemcitabine can cause neutropenia, fatigue, neuropathy, and gastrointestinal issues like nausea and diarrhea. Cisplatin is known for nephrotoxicity, ototoxicity, and myelosuppression. When these drugs are administered via PIPAC, the side effects may be reduced due to enhanced drug distribution and penetration into the tissue, potentially lowering the required dosage and minimizing systemic toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for bile duct cancer (cholangiocarcinoma), including systemic chemotherapies and targeted therapies. Notably, gemcitabine and cisplatin are commonly used in combination as a first-line treatment. While PIPAC itself is not FDA-approved, it represents an innovative approach to enhance drug distribution and tissue penetration. Other advanced delivery methods, such as transarterial chemoembolization (TACE) and radioembolization with yttrium-90, have been explored for their ability to deliver high concentrations of chemotherapy directly to the tumor site, similar to the goals of PIPAC.

What other types of research exist?

Promising novel alternatives to PIPAC for bile duct cancer patients include: 1) Stereotactic Body Radiotherapy (SBRT), which offers precise, high-dose radiation with improved overall survival. 2) Yttrium-90 radioembolization, which delivers targeted radiation directly to the tumor. 3) Hepatic Arterial Infusion (HAI) of chemotherapy, which provides high local drug concentrations with reduced systemic toxicity. 4) Combination therapies such as gemcitabine plus cisplatin, which have shown efficacy in advanced biliary tract cancers.

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Alkylating agents

Aerosolized Chemotherapy for Biliary Tract Cancer

Phase 1

Recruiting

Led By Mustafa Raoof, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy

Calculated creatinine clearance of >= 45 mL/min within 28 days prior to day 1 of protocol therapy

Must not have

Any prior systemic therapy treatment for advanced cholangiocarcinoma or gallbladder cancer

Bowel obstruction requiring specific interventions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before treatment (week 1) up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include typical chemotherapy reactions like nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. There may also be specific risks from the aerosol delivery such as abdominal pain or complications from laparoscopic surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 18 years old or older.

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

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

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had treatments for a blocked intestine.

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I have a history of cancer.

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Half of my liver is affected by cancer spread.

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I do not have any uncontrolled serious illnesses.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before treatment (week 1) up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before treatment (week 1) up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and before treatment (week 1) up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Change in patient-reported health state/quality of life and symptoms

Efficacy - PCI

Efficacy - PGRS

+5 more

Side effects data

From 2016 Phase 3 trial • 50 Patients • NCT02019277

70%

Diarrhoea

68%

Fatigue

56%

Neuropathy peripheral

54%

Alopecia

52%

Rash

46%

Nausea

38%

Upper respiratory tract infection

36%

Myalgia

34%

Vomiting

34%

Headache

28%

Muscle spasms

24%

Nail disorder

24%

Gastrooesophageal reflux disease

24%

Epistaxis

24%

Arthralgia

22%

Pain in extremity

20%

Back pain

20%

Urinary tract infection

18%

Dizziness

18%

Cough

18%

Constipation

16%

Neutropenia

16%

Dry skin

14%

Pyrexia

14%

Paronychia

14%

Dysgeusia

14%

Oropharyngeal pain

14%

Pruritus

14%

Hot flush

12%

Hypertension

12%

Dry eye

12%

Stomatitis

12%

Decreased appetite

12%

Musculoskeletal pain

12%

Insomnia

12%

Dyspnoea

10%

Peripheral sensory neuropathy

10%

Abdominal pain

10%

Mucosal inflammation

10%

Lethargy

Lacrimation increased

Febrile neutropenia

Rash pustular

Chills

Anaemia

Oedema peripheral

Oral candidiasis

Sinusitis

Anxiety

Rhinorrhoea

Acne

Erythema

Musculoskeletal chest pain

Injection site reaction

Skin lesion

Conjunctivitis

Nail infection

Chest pain

Tachycardia

Abdominal pain upper

Dry mouth

Dyspepsia

Chest discomfort

Pain

Hypocalcaemia

Bone pain

Depression

Dyspnoea exertional

Dermatitis acneiform

Lymphoedema

Weight decreased

Tooth extraction

Pulmonary embolism

Cellulitis

Device related infection

Gastroenteritis

Wound infection

Femur fracture

Breast cancer

Syncope

Psychotic disorder

Dermatitis bullous

Cardiac failure

Drug hypersensitivity

Gastritis

Dermatomyositis

Oesophagitis

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab, Pertuzumab, and Taxane

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (gemcitabine, cisplatin, nab-paclitaxel PIPAC)Experimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Gemcitabine

2017

Completed Phase 3

~1920

Nab-paclitaxel

2014

Completed Phase 3

~1950

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bile duct cancer include gemcitabine, cisplatin, and nab-paclitaxel. Gemcitabine works by inhibiting DNA synthesis, leading to cell death, while cisplatin forms DNA crosslinks that prevent cell division and induce apoptosis. Nab-paclitaxel stabilizes microtubules, hindering cell division. These mechanisms are crucial for bile duct cancer patients as they target rapidly dividing cancer cells. Enhanced drug distribution and penetration, as seen in PIPAC, improve the efficacy of these treatments by ensuring higher local drug concentrations and deeper tissue penetration, potentially reducing side effects and improving patient outcomes.

[A case of recurrent gall bladder cancer responding to chemotherapy with gemcitabine after endoscopic metallic biliary stent implantation].