Clinical trial NCT01825603: ADH-1, Gemcitabine Hydrochloride & Cisplatin in Treating Metastatic Pancreatic or Biliary Tract Cancer
Official title: A Phase I Study of ADH-1 and Gemcitabine Plus Cisplatin in Patients With Unresectable or Metastatic Pancreatic and Biliary Tract Cancers
Conditions: Ampulla of Vater Adenocarcinoma
Gallbladder Adenocarcinoma
Metastatic Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma
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
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.
Interventions:
description: Given IV
name: ADH-1
other_name: Exherin
type: Drug
description: Given IV
name: Cisplatin
other_name: Abiplatin
Blastolem
Briplatin
CDDP
Cis-diammine-dichloroplatinum
Cis-diamminedichloridoplatinum
Cis-diamminedichloro Platinum (II)
Cis-diamminedichloroplatinum
Cis-dichloroammine Platinum (II)
Cis-platinous Diamine Dichloride
Cis-platinum
Cis-platinum II
Cis-platinum II Diamine Dichloride
Cismaplat
Cisplatina
Cisplatinum
Cisplatyl
Citoplatino
Citosin
Cysplatyna
DDP
Lederplatin
Metaplatin
Neoplatin
Peyrone's Chloride
Peyrone's Salt
Placis
Plastistil
Platamine
Platiblastin
Platiblastin-S
Platinex
Platinol
Platinol- AQ
Platinol-AQ
Platinol-AQ VHA Plus
Platinoxan
Platinum
Platinum Diamminodichloride
Platiran
Platistin
Platosin
type: Drug
description: Given IV
name: Gemcitabine Hydrochloride
other_name: Difluorodeoxycytidine Hydrochloride
Gemzar
LY-188011
dFdCyd
type: Drug
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
Study arms:
design_group_description: Patients receive ADH-1 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.
design_group_title: Treatment (ADH-1, cisplatin, gemcitabine hydrochloride)
design_group_type: Experimental
Sponsor: University of Nebraska
Collaborators: National Cancer Institute
Fennec Pharmaceuticals, Inc.
Drug name mappings:
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
name: ADH-10001
lang: EN