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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before treatment (week 1) up to 1 year
Awards & highlights
Study Summary
This trial is testing a new way to give the drugs nab-paclitaxel, gemcitabine, and cisplatin to patients with biliary tract cancer that has spread to the lining of the abdomen. The new way uses a nebulizer and high-pressure injector during a laparoscopic procedure. The hope is that this new way will reduce side effects and make the chemotherapy more tolerable for patients.
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.Check my eligibility
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.See study design
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.
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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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
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%
Febrile neutropenia
8%
Rash pustular
8%
Lacrimation increased
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%
Psychotic disorder
2%
Syncope
2%
Dermatitis bullous
2%
Gastroenteritis
2%
Femur fracture
2%
Breast cancer
2%
Device related infection
2%
Wound infection
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
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
~1940
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,448 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
400 Patients Enrolled for Intrahepatic Cholangiocarcinoma
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,061 Total Patients Enrolled
3 Trials studying Intrahepatic Cholangiocarcinoma
1,145 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Mustafa Raoof, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
49 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any potential adverse effects from Nab-paclitaxel therapy?
"Nab-paclitaxel's safety and efficacy have been supported by only a few trials, leading to its rating of 1."
Answered by AI
Are there still opportunities available for individuals to participate in this experiment?
"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical experiment, which was initially advertised on April 11th 2022, is actively seeking volunteers. Approximately 12 individuals need to be recruited from 1 site for the trial's completion."
Answered by AI
What is the headcount of participants that have been admitted to this trial?
"Affirmative. According to the data on clinicaltrials.gov, this research initiative which was first posted in April 11th 2022 is still actively recruiting patients. The trial requires 12 participants from one medical centre for completion."
Answered by AI
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