A Phase I Study of ADH-1 and Gemcitabine Plus Cisplatin in Patients With Unresectable or Metastatic Pancreatic and Biliary Tract Cancers
I. To evaluate the toxicities and determine the recommended dose of ADH-1 given twice weekly
for 3 weeks in combination with cisplatin and fixed-dose rate gemcitabine (gemcitabine
hydrochloride) given on weeks 1 and 2 of the 3 week schedule for 3 cycles in patients with
locally advanced or metastatic pancreatic or biliary tract adenocarcinomas.
I. To evaluate changes in the levels of intercellular adhesion molecule 1 (ICAM-1),
E-selectin, vascular endothelial growth factor (VEGF), soluble vascular endothelial growth
factor receptor (VEGFR) and basic fibroblast growth factor (B-FGF) during therapy with
ADH-1, cisplatin and gemcitabine.
II. Radiographic assessment of disease status after 3 cycles of chemotherapy with ADH-1,
cisplatin and gemcitabine.
III. To evaluate progression-free and overall survival of patients with locally advanced or
metastatic pancreatic or biliary tract adenocarcinomas treated with ADH-1 given with
cisplatin and fixed dose rate gemcitabine for 3 cycles. Patients with stable or responsive
disease after 3 cycles will continue on maintenance cisplatin and fixed dose rate
Patients receive ADH-1 intravenously (IV) over 20-80 minutes on days 1, 4, 8, 11, 15, and
18, cisplatin IV and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment
repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable
toxicity. Patients with stable or responsive disease may receive maintenance therapy with
cisplatin and gemcitabine hydrochloride.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of ADH-1 when given in combination with gemcitabine hydrochloride and cisplatin determined by dose limiting toxicities (DLT), based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.
University of Nebraska
United States: Food and Drug Administration
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|