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ADH-1, Gemcitabine Hydrochloride & Cisplatin in Treating Metastatic Pancreatic or Biliary Tract Cancer

NCT01825603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-12-28

No results posted yet for this study

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.

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

Interventions

DRUG

ADH-1

Given IV

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • Adherex Technologies, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Jean L Grem, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-09
Primary Completion
2017-06-01
Completion
2017-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825603 on ClinicalTrials.gov