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

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ClinicalTrials.gov Identifier: NCT00536770
Recruitment Status : Suspended (DSMB)
First Posted : September 28, 2007
Last Update Posted : November 6, 2007
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: placebo + gemcitabine + erlotinib Drug: Placebo + gemcitabine Drug: calcitriol + gemcitabine Drug: calcitriol + gemcitabine + erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
Study Start Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 :
  1. Overall survival rate at 6 months

Secondary Outcome Measures :
  1. Objective response rate
  2. Duration of progression free survival
  3. Duration of overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536770

United States, Tennessee
Novacea Investigational Site
Nashville, Tennessee, United States
Sponsors and Collaborators

ClinicalTrials.gov Identifier: NCT00536770     History of Changes
Other Study ID Numbers: 011-017
First Posted: September 28, 2007    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents