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

Novacea132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

132

Conditions

Pancreatic Cancer

Interventions

placebo + gemcitabine + erlotinibDRUG

Placebo + gemcitabineDRUG

calcitriol + gemcitabineDRUG

calcitriol + gemcitabine + erlotinib

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novacea Investigational Site

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Overall survival rate at 6 months

Secondary Outcomes

Objective response rate

Duration of progression free survival

Duration of overall survival

Data from ClinicalTrials.gov

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