ADH-1, Gemcitabine Hydrochloride and Cisplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic or Biliary Tract Cancer That Cannot Be Removed by Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01825603|
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: ADH-1 Drug: Cisplatin Drug: Gemcitabine Hydrochloride Other: Laboratory Biomarker Analysis||Phase 1|
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 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of ADH-1 and Gemcitabine Plus Cisplatin in Patients With Unresectable or Metastatic Pancreatic and Biliary Tract Cancers|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: Treatment (ADH-1, cisplatin, gemcitabine hydrochloride)
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.
Other Name: Exherin
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
- Recommended dose of ADH-1, defined as the highest dose tested which results in dose-limiting toxicities in no more than 1 of 6 evaluable patients based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 21 days ]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.
- Changes in the levels of ICAM-1, E-selectin, VEGF, soluble VEGFR and B-FGF [ Time Frame: After all patients complete cycle 1, about 2 years after initial patient enrolled ]Summarized using descriptive statistics
- Progression-free survival [ Time Frame: From the first date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 2 years ]Plotted following the method of Kaplan and Meier.
- Survival [ Time Frame: From the first date of therapy until the date of death from any cause, assessed up to 2 years ]Plotted following the method of Kaplan and Meier.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825603
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Jean Grem||University of Nebraska|