Drug Combination for Biliary Tract Cancer
(AX-CSARC Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJennifer Spratlin, MD FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AHS Cancer Control Alberta

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?You are being asked to take part in this study because you have a biliary cancer that is incurable and has spread to other organs. Chemotherapy is often used to help shrink the cancer temporarily and may improve survival. In Canada, the combination of gemcitabine and cisplatin is the chemotherapy combination used to treat biliary cancer that has spread. There is no other known treatment for biliary cancer that has spread to other organs. It is hoped that this new combination of drugs (nab-paclitaxel, gemcitabine, and cisplatin) will improve the tumor shrinkage rate. This study is being done because we do not know whether 2 or 3 chemotherapy drugs is better to treat biliary cancers. We hope to learn whether giving nab-paclitaxel, gemcitabine, and cisplatin together in patients with biliary cancer can increase tumor shrinkage without too many side effects. The purpose of this study is to find out what effects (good and bad) nab-paclitaxel, gemcitabine, and cisplatin has on you and your biliary cancer.

Eligibility Criteria

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.

+7 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 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: