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

Sponsors and Collaborators:	Novacea Schering-Plough
Information provided by:	Novacea
ClinicalTrials.gov Identifier:	NCT00536770

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: placebo + gemcitabine + erlotinib Drug: Placebo + gemcitabine Drug: calcitriol + gemcitabine Drug: calcitriol + gemcitabine + erlotinib	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Erlotinib Erlotinib hydrochloride Calcitriol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma

Further study details as provided by Novacea:

Primary Outcome Measures:

Overall survival rate at 6 months

Secondary Outcome Measures:

Objective response rate
Duration of progression free survival
Duration of overall survival

Estimated Enrollment:	132
Study Start Date:	September 2007

Arms	Assigned Interventions
A: Placebo Comparator Placebo + gemcitabine	Drug: Placebo + gemcitabine
B: Placebo Comparator Placebo + gemcitabine + erlotinib	Drug: placebo + gemcitabine + erlotinib
C: Active Comparator DN-101 + gemcitabine	Drug: calcitriol + gemcitabine
D: Active Comparator DN-101 + gemcitabine + erlotinib	Drug: calcitriol + gemcitabine + erlotinib

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536770

Locations

United States, Tennessee
Novacea Investigational Site
Nashville, Tennessee, United States

Sponsors and Collaborators

Novacea

Schering-Plough

More Information

Study ID Numbers:	011-017
Study First Received:	September 26, 2007
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00536770
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Erlotinib
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Calcitriol
Calcium, Dietary
Digestive System Diseases

Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Calcium Channel Agonists
Enzyme Inhibitors
Bone Density Conservation Agents
Cardiovascular Agents

Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Micronutrients

ClinicalTrials.gov processed this record on January 15, 2009