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Alkylating agents

Nab-paclitaxel for Cholangiocarcinoma

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

Study 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

Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of surgery up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Completion of all preoperative and operative therapy

Incidence of adverse events

Secondary outcome measures

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 • 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

Febrile neutropenia

Rash pustular

Lacrimation increased

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

Psychotic disorder

Syncope

Dermatitis bullous

Gastroenteritis

Femur fracture

Breast cancer

Device related infection

Wound infection

Cardiac failure

Drug hypersensitivity

Gastritis

Dermatomyositis

Oesophagitis

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab, Pertuzumab, and Taxane

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,542 Total Patients Enrolled

5 Trials studying Cholangiocarcinoma

86 Patients Enrolled for Cholangiocarcinoma

CelgeneIndustry Sponsor

636 Previous Clinical Trials

128,940 Total Patients Enrolled

1 Trials studying Cholangiocarcinoma

21 Patients Enrolled for Cholangiocarcinoma

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,548 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03579771 — Phase 2

Cholangiocarcinoma Research Study Groups: Gemcitabine, cisplatin, nab-paclitaxel

Cholangiocarcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03579771 — Phase 2

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03579771 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions has Nab-paclitaxel been instrumental in managing?

"Nab-paclitaxel is therapeutically beneficial for treating neoplasm metastasis, acute pyelonephritis (APN), and shock hypovolemic."

Answered by AI

Are researchers currently recruiting individuals for this clinical trial?

"Unfortunately, the clinicaltrials.gov page informs us that this trial is no longer recruiting candidates. The study was first unveiled on September 26th 2018 and its last update took place October 5th 2022. Despite this, there are still 1,722 other medical trials actively seeking participants at present."

Answered by AI

Is Nab-paclitaxel a viable and secure treatment option?

"Nab-paclitaxel was rated a 2 on our safety scale as, despite having some data attesting to its security, there is not yet any evidence of the drug's efficacy."

Answered by AI

How many individuals are currently participating in this research study?

"This trial is not presently gathering patients. As initially posted on September 26 2018 and last edited on October 5 2022, it has been removed from the recruitment process. If you are searching for other studies that may fit your criteria, cholangiocarcinoma recruiting efforts have 199 open clinical trials while 1523 medical centres are currently looking for participants to take part in Nab-paclitaxel research."

Answered by AI

To what extent has Nab-paclitaxel been evaluated in other research projects?

"Nab-paclitaxel was first explored at City of Hope Comprehensive Cancer Centre in 1997 and since then 2603 trials have concluded. Right now, 1523 active studies are taking place with a multitude conducted from Jacksonville, Florida."

Answered by AI

Are there multiple American sites conducting this investigation?

"Currently, 9 sites are administering the trial. These include Jacksonville, Scottsdale and Atlanta in addition to 6 other areas. For maximum convenience, participants should pick a centre that is close by their home address."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery in Patients With High-Risk Liver Bile Duct Cancer

Shishir Kumar Maithel 2018. "Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery in Patients With High-Risk Liver Bile Duct Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03579771.

All > Bile Duct Cancer