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SWOG S1815

Trial

Clinical Trial Title

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-paclitaxel vs. Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

Trial Status

Closed to Enrollment

Start Date

December 3, 2018

Trial Type

Cancer - Adult Oncology

Specific Condition

Biliary tract cancer

Description

This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.

Eligibility Criteria

Eligibility Criteria

  • Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer.
  • Patients must have documented metastatic or locally advanced unresectable disease on CT or MR imaging.
  • Patient must not have a current diagnosis of ampullary cancer.
  • Patients must not have received prior systemic therapy for the current metastatic or locally advanced biliary cancer.
  • Patient must not have received adjuvant therapy within 6 months prior to registration.
  • Patients must have a Zubrod Performance Status of 0 or 1.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Monday, March 22, 2021 02:43:46 PM