Drug Combination for Biliary Tract Cancer
(AX-CSARC Trial)
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.12345Why 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.23567
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nab-paclitaxel, gemcitabine, and cisplatin in 3-week cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
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:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
AHS Cancer Control Alberta
Lead Sponsor
Celgene
Industry Sponsor
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
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, ...
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.
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 ...
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, ...
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 ...
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 ...
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.
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