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

NCT ID: NCT00536770

Last Updated: 2007-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Placebo + gemcitabine

Group Type PLACEBO_COMPARATOR

Placebo + gemcitabine

Intervention Type DRUG

B

Placebo + gemcitabine + erlotinib

Group Type PLACEBO_COMPARATOR

placebo + gemcitabine + erlotinib

Intervention Type DRUG

C

DN-101 + gemcitabine

Group Type ACTIVE_COMPARATOR

calcitriol + gemcitabine

Intervention Type DRUG

D

DN-101 + gemcitabine + erlotinib

Group Type ACTIVE_COMPARATOR

calcitriol + gemcitabine + erlotinib

Intervention Type DRUG

Interventions

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placebo + gemcitabine + erlotinib

Intervention Type DRUG

Placebo + gemcitabine

Intervention Type DRUG

calcitriol + gemcitabine

Intervention Type DRUG

calcitriol + gemcitabine + erlotinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role collaborator

Novacea

INDUSTRY

Sponsor Role lead

Locations

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Novacea Investigational Site

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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011-017

Identifier Type: -

Identifier Source: org_study_id