Cholangiocarcinoma Clinical Trial
Official title:
A Multi-Institutional, Single Arm, Two-Stage Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma
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.
Advanced cholangiocarcinomas (CCAs) are aggressive tumors with median survival time after
diagnosis of less than 12 months, and five-year overall survival (OS) of ~5% with systemic
chemotherapy. Currently available systemic therapies for CCA are largely ineffective, thus
the rationale for the proposed research is to investigate targeted delivery of chemotherapy.
The goal of this study is to evaluate the efficacy of gemcitabine plus nab-paclitaxel in
patients with advanced CCA. This is based on the premise that nab-paclitaxel binds to SPARC
(secreted protein acidic and rich in cysteine) through its interaction with albumin, leading
to an increase in intra-tumoral concentration of gemcitabine through decreased deoxycytidine
deaminase (CDA) enzyme. We hope to improve on the OS of patients with advanced CCA through
the use of the synergistic combination of nab-paclitaxel and gemcitabine to specifically
target the SPARC protein in the peri-tumoral stroma. We aim to provide critical data to
further develop pharmacologic strategies to target the desmoplastic stroma in order to
increase chemotherapy responsiveness of CCAs.
We will also examine whether circulating tumor cell (CTC) levels with targeted gene
expression analysis and stromal SPARC levels correlate with patient outcome and thus serve as
prognostic biomarkers. We will evaluate the role of Human Equilibrative Nucleoside
Transporter 1 (hENT1), CDA and tumor fibrosis as additional prognostic and predictive
biomarkers in CCA. This clinical trial hopes to improve on the poor prognosis of patients
with advanced CCA by establishing the activity of a platinum-free doublet, nab-paclitaxel
plus gemcitabine that has shown clear clinical benefit in pancreatic cancer which has close
biological parallels to CCA.
A maximum of 70 patients will be enrolled to attain 67 eligible/evaluable patients. Stage I
will enroll 37 patients. If 21 or more patients are alive and progression-free at 6 months,
the study will proceed to Stage II and an additional 33 patients will be enrolled.
Procurement of archived tissue, if available, from a previous diagnostic biopsy is mandatory
for enrollment. If not available, this will not preclude participation in the trial, nor will
additional biopsies be performed for research purposes only.
Optional blood samples will be requested.
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