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

This study has suspended participant recruitment.
(DSMB)
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00536770
First received: September 26, 2007
Last updated: November 2, 2007
Last verified: November 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on October 23, 2014