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Br J Cancer. 2017 Jul 11;117(2):189-194. doi: 10.1038/bjc.2017.160. Epub 2017 Jun 20.

Phase 2 study of combination SPI-1620 with docetaxel as second-line advanced biliary tract cancer treatment.

Author information

1
Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center &Research Institute, 12902 Magnolia Drive FOB-2, Tampa, FL 33612, USA.
2
Division of Oncology, Department of Medicine, University of Washington, 825 Eastlake Avenue E, G4-833, Seattle, WA 98109-1023, USA.
3
Division of Medical Oncology, Department of Medicine, Washington University School of Medicine, 5225 Midamerica Plaza, St Louis, MO 63129, USA.
4
Department of Radiology, Washington University School of Medicine, 5225 Midamerica Plaza, St Louis, MO 63129, USA.
5
Department of Pathology, Washington University School of Medicine, 5225 Midamerica Plaza, St Louis, MO 63129, USA.
6
Associate Cancer Center Director for Translational Research, Gibbs Cancer Center &Research Institute, 380 Serpentine Drive, Suite 200, Spartanburg, SC 29303, USA.
7
Associates in Oncology &Hematology, 2205 McCallie Avenue, Suite 502, Chattanooga, TN 37404, USA.
8
Associate Director of Biostatistics, Spectrum Pharmaceuticals Inc., 157 Technology Drive, Irvine, CA 92618, USA.
9
West Cancer Center, 7945 Wolf River Boulevard, Memphis, TN 38138, USA.

Abstract

BACKGROUND:

This multicentre, open-label study evaluated the efficacy and safety of SPI-1620, an analogue of endothelin-1, administered in combination with docetaxel as second-line treatment for patients with advanced biliary tract cancer (ABTC).

METHODS:

Eligible patients received continuous cycles of combination therapy with SPI-1620 (11 μg m-2) and docetaxel (75 mg m-2) intravenously every 3 weeks until disease progression (PD) or intolerable toxicity. Tumour response was evaluated using computed tomography or magnetic resonance imaging every 2 cycles (6 weeks). The primary efficacy end point was progression-free survival (PFS); secondary end points included overall response rate (ORR), duration of response, and overall survival (OS) that were estimated using the Kaplan-Meier method.

RESULTS:

Of the 30 enrolled patients, 25 patients had qualifying events (PD or death), 1 patient was nonevaluable, and 4 patients were censored at the time of their last tumour assessment. Our primary end point of PFS ⩾5 months was not reached. Median PFS was 2.6 months (95% confidence interval (CI): 1.4-2.8), ranging from 0.7 to 8.4 months. The ORR was 10.3% (95% CI: 0.02-0.27). Eleven additional patients achieved stable disease. The OS was 4.87 months. The most common grade 3-4 toxicities were febrile neutropenia and neutropenia.

CONCLUSIONS:

The addition of docetaxel to SPI-1620 in second-line ABTC did not meet the pre-specified primary end point of PFS ⩾5 months in unselected patient population.

PMID:
28632730
PMCID:
PMC5520510
DOI:
10.1038/bjc.2017.160
[Indexed for MEDLINE]
Free PMC Article

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