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Alkylating agents
Nab-paclitaxel for Bile Duct Cancer
Phase 2
Waitlist Available
Led By Shishir Maithel, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of surgery up to 3 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial will study how well gemcitabine, cisplatin, and nab-paclitaxel work before surgery in treating high-risk bile duct cancer in the liver.
Eligible Conditions
- Bile Duct Cancer
- Liver Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of surgery up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of surgery up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Completion of all preoperative and operative therapy
Incidence of adverse events
Secondary study objectives
Overall survival (OS)
Radiological response rate defined as the percentage of patients who will have complete response (CR), partial response (PR) or stable disease (SD) after the neoadjuvant therapy
Recurrence-free survival (RFS)
Side 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
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Gemcitabine, cisplatin, nab-paclitaxelExperimental Treatment3 Interventions
Participants receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Cisplatin
FDA approved
Gemcitabine
FDA approved
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,887 Total Patients Enrolled
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,401 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,580 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had or currently have another type of cancer, except for non-melanoma skin cancer and very early stage cancers.You have a large blood vessel involved, but it can still be surgically removed.You are currently using alcohol or illegal drugs in a harmful way.You have swollen or affected lymph nodes in the nearby area.You have had an allergic reaction or bad reaction to any of the study drugs in the past.You have multiple tumors or small lesions in the same part of the liver that can be surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine, cisplatin, nab-paclitaxel
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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