Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma

Summary

Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy. The purpose of this study is to evaluate the effectiveness and safety of the combination of nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the length of time during and after treatment, that the CCA does not get worse.

Timeline

Start

2014-12-09

Primary completion

2016-09-24

Completion

2017-10-01

Outcome

Missed primary endpoint

paper The observed 6-month PFS rate of 61% (95% CI, 48%-73%) did not favor the alternative hypothesis. PMID 30178032 ↗

paper Although the trial did not meet its primary efficacy end point PMID 30178032 ↗

Publications

• Results Sahai V, Catalano PJ, Zalupski MM, Lubner SJ, Menge MR, Nimeiri HS, Munshi HG, Benson AB 3rd, O'Dwyer PJ. Nab-Paclitaxel and Gemcitabine as First-line Treatment of Advanced or Metastatic Cholangiocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1707-1712. doi: 10.1001/jamaoncol.2018.3277.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1000 mg/m2	—
Subject	Nab-paclitaxel	Small molecule	125 mg/m2	Intravenous

Indications