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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 belowSelect...
My cancer has spread to the lining of my abdomen and can be seen on scans.
Select...
My kidney function, measured by creatinine clearance, is adequate.
Select...
I am 18 years old or older.
Select...
I have recovered from the side effects of my previous cancer treatment.
Select...
My cancer is confirmed to be in the bile ducts or gallbladder.
Select...
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:Select...
I have received treatment for advanced bile duct or gallbladder cancer.
Select...
I have had treatments for a blocked intestine.
Select...
I have a history of cancer.
Select...
Half of my liver is affected by cancer spread.
Select...
I do not have any uncontrolled serious illnesses.
Select...
I have had, or currently have, cancer spread to my brain.
Select...
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
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 moreSide effects data
From 2016 Phase 3 trial • 50 Patients • NCT0201927770%
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
8%
Lacrimation increased
8%
Febrile neutropenia
8%
Rash pustular
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Device related infection
2%
Gastroenteritis
2%
Wound infection
2%
Femur fracture
2%
Breast cancer
2%
Syncope
2%
Psychotic disorder
2%
Dermatitis bullous
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
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
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].
[A case of recurrent gall bladder cancer responding to chemotherapy with gemcitabine after endoscopic metallic biliary stent implantation].
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,593 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,075 Total Patients Enrolled
Mustafa Raoof, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
49 Total Patients Enrolled
Daneng Li, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatments for a blocked intestine.I have not taken any strong antibiotics in the last 14 days.I haven't taken strong CYP3A4 drugs in the last 14 days.I have a history of cancer.Half of my liver is affected by cancer spread.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've had a full medical check-up in the last 28 days.I have moderate to severe numbness, tingling, or pain in my hands or feet.My cancer is confirmed to be in the bile ducts or gallbladder.I can follow all the study's required procedures.I finished my additional cancer treatment less than 6 months ago.I am a woman who can have children and have a negative pregnancy test.I am 18 years old or older.I have received treatment for advanced bile duct or gallbladder cancer.I have recovered from the side effects of my previous cancer treatment.I do not have any uncontrolled serious illnesses.I have had, or currently have, cancer spread to my brain.My cancer has spread, as shown in recent scans.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (gemcitabine, cisplatin, nab-paclitaxel PIPAC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.