A Phase III Study of Gemcitabine and Cisplatin with or without Nab-Paclitaxel to Treat Advanced Biliary Tract Cancers

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Full Title

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers (S1815) (CIRB)

Purpose

The purpose of this study is to see if adding nab-paclitaxel to treatment with gemcitabine and cisplatin is more effective than gemcitabine and cisplatin (the standard of care) for patients with advanced biliary cancers (cholangiocarcinoma or gallbladder cancer). Nab-paclitaxel is a standard treatment with gemcitabine for patients with pancreatic cancer and may improve treatment outcomes for patients with other hepatobiliary cancers.

Patients will be randomly assigned to receive gemcitabine, cisplatin, and nab-paclitaxel or gemcitabine and cisplatin. All of the treatments in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic or inoperable cholangiocarcinoma or gallbladder cancer and may not have received treatment for advanced disease.
  • Treatment received after surgery must have been completed more than 6 months before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Imane El Dika at 646-888-6826.

Protocol

19-480

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators