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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	September 26, 2007
Last Updated Date	November 2, 2007
Start Date ^†	September 2007
Current Primary Outcome Measures ^† (submitted: September 27, 2007)	Overall survival rate at 6 months
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00536770 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: September 27, 2007)	Objective response rate Duration of progression free survival Duration of overall survival
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer
Official Title ^†	A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
Brief Summary	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
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Pancreatic Cancer
Intervention ^†	Drug: placebo + gemcitabine + erlotinib Drug: Placebo + gemcitabine Drug: calcitriol + gemcitabine Drug: calcitriol + gemcitabine + erlotinib
Study Arms / Comparison Groups	Placebo Comparator: Placebo + gemcitabine Placebo Comparator: Placebo + gemcitabine + erlotinib Active Comparator: DN-101 + gemcitabine Active Comparator: DN-101 + gemcitabine + erlotinib
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Suspended
Enrollment ^†	132
Completion Date
Primary Completion Date
Eligibility 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00536770
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Novacea
Collaborators ^††	Schering-Plough
Investigators ^†
Information Provided By	Novacea
Verification Date	November 2007
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.