A Study Of Gemcitabine ± Erlotinib And DN-101 Versus Gemcitabine ± Erlotinib And Placebo In Patients With Advanced Pancreatic Cancer

Study Overview

A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer

The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.

N/A

Pancreatic Cancer

DRUG: placebo + gemcitabine + erlotinib
DRUG: Placebo + gemcitabine
DRUG: calcitriol + gemcitabine
DRUG: calcitriol + gemcitabine + erlotinib

011-017

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-09-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2007-11-02
First Submitted that Met QC Criteria 2007-09-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2007-11-06
First Posted (ESTIMATED) 2007-09-28	Results First Posted N/A	Last Verified 2007-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
PLACEBO_COMPARATOR: A Placebo + gemcitabine	DRUG: Placebo + gemcitabine
PLACEBO_COMPARATOR: B Placebo + gemcitabine + erlotinib	DRUG: placebo + gemcitabine + erlotinib
ACTIVE_COMPARATOR: C DN-101 + gemcitabine	DRUG: calcitriol + gemcitabine
ACTIVE_COMPARATOR: D DN-101 + gemcitabine + erlotinib	DRUG: calcitriol + gemcitabine + erlotinib

Primary Outcome Measures	Measure Description	Time Frame
Overall survival rate at 6 months

Secondary Outcome Measures	Measure Description	Time Frame
Objective response rate
Duration of progression free survival
Duration of overall survival

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer
Performance status 0, 1,or 2
Adequate bone marrow, renal and hepatic function

Prior chemotherapy or radiation therapy for pancreatic cancer
Prior treatment for other cancers in last 6 months
Cancer of the brain or spine
Active uncontrolled infection
Hypercalcemia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Schering-Plough

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record