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Clinical Trial Summary

This phase I trial studies the side effects and best dose of ADH-1 when given together with gemcitabine hydrochloride and cisplatin in treating patients with pancreatic or biliary tract cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread to other parts of the body (metastatic) and cannot be removed by surgery. ADH-1 may stop the growth of cancer cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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. Giving ADH-1 together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.


Clinical Trial Description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 gemcitabine. OUTLINE: This is a dose-escalation study of ADH-1. 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. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Ampulla of Vater Adenocarcinoma
  • Biliary Tract Neoplasms
  • Cholangiocarcinoma
  • Gallbladder Adenocarcinoma
  • Gallbladder Neoplasms
  • Klatskin Tumor
  • Metastatic Pancreatic Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Neoplasms
  • Stage III Ampulla of Vater Cancer
  • Stage III Intrahepatic Cholangiocarcinoma
  • Stage III Pancreatic Cancer
  • Stage IIIA Gallbladder Cancer
  • Stage IIIA Hilar Cholangiocarcinoma
  • Stage IIIB Gallbladder Cancer
  • Stage IIIB Hilar Cholangiocarcinoma
  • Stage IV Ampulla of Vater Cancer
  • Stage IVA Gallbladder Cancer
  • Stage IVA Hilar Cholangiocarcinoma
  • Stage IVA Intrahepatic Cholangiocarcinoma
  • Stage IVA Pancreatic Cancer
  • Stage IVB Gallbladder Cancer
  • Stage IVB Hilar Cholangiocarcinoma
  • Stage IVB Intrahepatic Cholangiocarcinoma
  • Stage IVB Pancreatic Cancer

NCT number NCT01825603
Study type Interventional
Source University of Nebraska
Contact
Status Completed
Phase Phase 1
Start date April 9, 2013
Completion date June 1, 2017

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