Drug Combination for Biliary Tract Cancer

(AX-CSARC Trial)

Not currently recruiting at 1 trial location

Overseen By Jennifer Spratlin, MD FRCPC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

Must not be taking: Immunosuppressants, Myelosuppressants, Anticonvulsants, others

Disqualifiers: Prior chemotherapy, Active infection, Uncontrolled conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of three chemotherapy drugs—nab-paclitaxel, gemcitabine, and cisplatin (also known as Platinol)—to determine if they can more effectively shrink tumors in individuals with biliary cancer that has metastasized. Researchers aim to assess whether using all three drugs together is more effective than the standard two-drug treatment. The trial seeks participants with advanced biliary tract cancer that is inoperable and has not yet been treated with chemotherapy or radiation. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of nab-paclitaxel, gemcitabine, and cisplatin is generally well-tolerated by patients with advanced biliary tract cancer. One study found that this treatment allowed patients to live without their cancer worsening for about 11.8 months on average and to live overall for about 19.2 months on average. These results suggest the treatment is effective and safe for extended use.

A study from Korea confirmed the safety of this drug combination, supporting earlier research findings. While side effects can occur, they are usually manageable with proper medical care. Some patients might experience fatigue or nausea, common with many cancer treatments. Overall, evidence supports the safety of this drug combination for treating advanced biliary tract cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment combination for biliary tract cancer because it introduces nab-paclitaxel alongside the standard drugs cisplatin and gemcitabine. Nab-paclitaxel enhances the delivery of chemotherapy agents to cancer cells, potentially increasing the effectiveness of the treatment. This combination aims to improve outcomes by leveraging nab-paclitaxel's ability to better target and penetrate tumors, offering a fresh approach compared to existing therapies. This innovation could lead to improved survival rates and better management of the disease.

What evidence suggests that this drug combination could be effective for biliary cancer?

In this trial, participants will receive a combination of three drugs—nab-paclitaxel, gemcitabine, and cisplatin—to treat advanced biliary tract cancer. Studies have shown that this combination can be effective. Specifically, one study reported that patients lived for about 11.8 months without their cancer worsening and had an overall survival time of 19.2 months, suggesting longer survival without cancer progression compared to other treatments. However, another study found that this combination did not extend survival beyond standard treatments. Overall, these drugs together might help shrink tumors and improve survival, but results can vary. ^{2 3 5 6 7}

Who Is on the Research Team?

Jennifer Spratlin, MD FRCPC

Principal Investigator

Alberta Health services

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic biliary tract cancer that hasn't been treated with palliative systemic therapy or radiation. Participants should have a life expectancy of at least 3 months, good performance status (able to carry out daily activities), and adequate blood counts and liver function tests.

Inclusion Criteria

I am fully active or can carry out light work.

My bilirubin levels are not more than 1.5 times the upper limit of normal.

My hemoglobin level is at least 9 g/dL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nab-paclitaxel, gemcitabine, and cisplatin in 3-week cycles

1 year

Day 1 and 8 of each 21-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin
• Gemcitabine
• nab-paclitaxel

Trial Overview The study is testing the effectiveness of combining three chemotherapy drugs: nab-paclitaxel, gemcitabine, and cisplatin in patients with biliary tract cancer. The goal is to see if this combination can shrink tumors more effectively than current treatments without causing excessive side effects.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Eligible patients will receive nab-paclitaxel in combination with gemcitabine + cisplatin at the recommended phase II dose based on the phase I study completed in metastatic pancreas cancer patients. The doses of study drugs will be as follows: * nab-Paclitaxel 100 mg/m2 day 1 and 8 every 21 days * Cisplatin 25 mg/m2 day 1 and 8 every 21 days * Gemcitabine 800 mg/m2 day 1 and 8 every 21 days Nab-paclitaxel will be administered first followed by cisplatin and then gemcitabine on day 1 and 8 of each treatment cycle. Cycles will be 3 weeks in length (21 days).

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Celgene

Industry Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40819029/

Nab-paclitaxel plus cisplatin versus gemcitabine ... Nab-paclitaxel plus cisplatin versus gemcitabine plus cisplatin as first-line treatment in advanced biliary tract cancer: results of a multicentre, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9474496/

Real-World Outcomes of Gemcitabine, Cisplatin, and Nab ... Gemcitabine, cisplatin, and nab-paclitaxel did not improve the PFS or OS compared to that achieved by standard chemotherapy in patients with advanced BTC.

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2730639

Gemcitabine, Cisplatin, and nab-Paclitaxel for the ... Administration of nab-paclitaxel plus gemcitabine-cisplatin resulted in median progression-free survival of 11.8 months and median overall survival of 19.2 ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14581-3

Nab-paclitaxel plus cisplatin versus ... - BMC Cancer A clinical trial carried out evaluate the efficacy of combining S-1 with nab-paclitaxel as first-line treatment for (Advanced Bile tract cancer, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02392637

Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel ... This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34394748/

Real-world efficacy and safety of nab-paclitaxel plus ... Gem/Cis/nab-P showed favorable real-life efficacy and safety outcomes in Korean patients with advanced BTC, which was consistent with the phase II trial ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37846469/

A Single-Arm Phase II Study of Nab-Paclitaxel Plus ... We aim to evaluate the efficacy and safety of nab-paclitaxel plus gemcitabine and cisplatin regimen in Chinese advanced BTC patients.