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Alkylating agents

Chemotherapy for Biliary Tract Cancer

Phase 3
Waitlist Available
Led By Rachna Shroff
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must not have received adjuvant therapy within 6 months prior to registration
Patient must not have a current diagnosis of ampullary cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is studying gemcitabine hydrochloride, cisplatin, and nab-paclitaxel to see how well they work in treating patients with biliary tract cancer.

Who is the study for?
This trial is for adults with newly diagnosed advanced biliary tract cancers, including gallbladder and bile duct cancers. Participants must not have had previous systemic therapy for their cancer or adjuvant therapy within the last 6 months. They should be in good physical condition (Zubrod performance status of 0 or 1) and cannot have a history of significant peripheral neuropathy or other active cancers, except certain treated skin cancers and early-stage cured cancers.Check my eligibility
What is being tested?
The study is testing how well gemcitabine hydrochloride and cisplatin work when given together compared to when they are combined with nab-paclitaxel in treating advanced biliary tract cancers. The goal is to determine if adding nab-paclitaxel improves treatment outcomes.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, hair loss, numbness in fingers or toes (neuropathy), low blood cell counts leading to increased infection risk, bleeding problems, tiredness, kidney issues, liver function changes, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had additional cancer treatment in the last 6 months.
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I do not have a diagnosis of ampullary cancer.
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I haven't had systemic therapy for my advanced biliary cancer.
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I have been diagnosed with a type of bile duct or gallbladder cancer.
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I do not have any infections that need treatment with drugs.
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My cancer is confirmed as adenocarcinoma with pancreaticobiliary origin, with no pancreatic lesions.
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I have never had severe nerve damage.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Overall survival (OS)
Secondary outcome measures
Changes in carbohydrate antigen 19-9 (CA 19-9) levels
Disease control rate as measured by RECIST 1.1 criteria
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (cisplatin, gemcitabine hydrochloride)Experimental Treatment2 Interventions
Patients receive cisplatin IV over 60 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (nab-paclitaxel, cisplatin, gemcitabine hydrochloride)Experimental Treatment3 Interventions
Patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Albumin human
FDA approved
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,799 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,158 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,194 Total Patients Enrolled
4 Trials studying Intrahepatic Cholangiocarcinoma
1,157 Patients Enrolled for Intrahepatic Cholangiocarcinoma

Media Library

Intrahepatic Cholangiocarcinoma Research Study Groups: Arm II (cisplatin, gemcitabine hydrochloride), Arm I (nab-paclitaxel, cisplatin, gemcitabine hydrochloride)

Frequently Asked Questions

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

Are there other examples in which Cisplatin has been used in a clinical setting?

"City of Hope Comprehensive Cancer Center was the first to study cisplatin in 1997. Since that time, there have been 2634 completed studies with 1636 more currently underway. Many of these live trials are being conducted in Redmond, Oregon."

Answered by AI

Which medical facilities are currently conducting this research?

"There are 100 patients being recruited for this study from locations such as Saint Charles Health System-Redmond in Redmond, Baptist Memorial Hospital and Cancer Center-Union County in New Albany, and Cancer Treatment Centers of America in Tulsa, as well as 100 other locations."

Answered by AI

Has Cisplatin been greenlit by the FDA?

"Cisplatin has received a score of 3 because there is both anecdotal and experimental evidence to support its efficacy, as well as extensive safety data."

Answered by AI

What diseases has Cisplatin been shown to be most effective against?

"Cisplatin is often used as a treatment for neoplasm metastasis, but it can also help patients with acute pyelonephritis, shock, hypovolemic, and locally advanced non-small cell lung cancer."

Answered by AI

Are there any current openings for people who want to enroll in this research project?

"Unfortunately, this particular study has already closed recruitment. The trial was originally posted on December 3, 2018 but was last edited on October 8, 2021. If you are looking for other studies, there are currently 2791 clinical trials actively searching for patients with intrahepatic cholangiocarcinoma and 1636 trials for Cisplatin actively searching for participants."

Answered by AI

How many people total are participating in this experiment?

"This trial is not actively enrolling patients at the moment. The trial was initially posted on December 3rd, 2018 and was last updated on October 8th, 2021. If you are looking for other trials, there are 2791 trials related to intrahepatic cholangiocarcinoma and 1636 Cisplatin trials that are currently looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Regional Cancer Center-Lee Memorial Health System
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried other treatments since 7/22, and would love an opportunity for new treatments that work because my first session with gem/cis/imfinzi worked to shrink my tumors until I finished the treatment regimen, went on maintenance imfinzi and had disease progression.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do screenings take? When will trial start? How long is treatment regimen? What can affect who you choose? Are mutations required?
PatientReceived 2+ prior treatments
~74 spots leftby Mar 2025