What side effects are associated with this type of intervention?

The most common treatments for intrahepatic cholangiocarcinoma, such as gemcitabine, cisplatin, and nab-paclitaxel, have several known side effects. Gemcitabine can cause nausea, vomiting, diarrhea, neutropenia, and thrombocytopenia. Cisplatin is associated with nephrotoxicity, ototoxicity, nausea, vomiting, and myelosuppression. Nab-paclitaxel often leads to neuropathy, fatigue, neutropenia, and diarrhea. When these drugs are combined, the likelihood and severity of these side effects can increase.

What prior FDA approvals exist?

The FDA has approved several treatments for intrahepatic cholangiocarcinoma, including gemcitabine and cisplatin, which are commonly used in combination. Gemcitabine works by inhibiting DNA synthesis, while cisplatin forms DNA crosslinks to prevent cell division. Nab-paclitaxel, which stabilizes microtubules, is being studied in combination with these drugs to enhance their efficacy. These treatments aim to stop the growth and spread of cancer cells by targeting different mechanisms within the cell.

What other types of research exist?

Promising novel alternatives for intrahepatic cholangiocarcinoma treatment in 2024 include targeted therapies and immunotherapies. Dabrafenib plus Trametinib has shown efficacy in patients with BRAFV600E mutations. Pembrolizumab is an option for tumors with deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H). Additionally, TRK inhibitors like Larotrectinib or Entrectinib are viable for TRK fusion-positive tumors. These therapies offer targeted approaches based on specific genetic alterations in the tumor.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing how well two cancer-fighting drugs work together, and whether adding a third drug makes them more effective in treating patients with advanced biliary tract cancers. The drugs aim to kill cancer cells, stop them from dividing, or prevent them from spreading.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Changes in Carbohydrate Antigen 19-9 (CA 19-9) Levels

Disease Control Rate as Measured by RECIST 1.1 Criteria

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs.

+2 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Do I qualify?Apply below to find out

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

Common treatments for intrahepatic cholangiocarcinoma, such as gemcitabine, cisplatin, and nab-paclitaxel, work through distinct mechanisms. Gemcitabine inhibits DNA synthesis, preventing cancer cell replication. Cisplatin forms DNA crosslinks, causing DNA damage and triggering cell death. Nab-paclitaxel stabilizes microtubules, disrupting cell division. These mechanisms are important for patients because they target cancer cells at various stages of the cell cycle, potentially enhancing treatment effectiveness and justifying the use of combination therapies.

ABT737 enhances cholangiocarcinoma sensitivity to cisplatin through regulation of mitochondrial dynamics.Cancer cells acquire mitotic drug resistance properties through beta I-tubulin mutations and alterations in the expression of beta-tubulin isotypes.