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Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Patients With Advanced or Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00267020
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : October 7, 2009
Information provided by:
Eli Lilly and Company

Brief Summary:
The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in patients with pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasm Drug: enzastaurin Drug: gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Study Start Date : December 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: enzastaurin
1200 mg loading dose then 500 mg, oral, daily, six 28 day cycles
Other Name: LY317615

Drug: gemcitabine
1000 mg/m2, IV, days 1, 8 and 15 per cycle, six 28 day cycles
Other Names:
  • LY188011
  • Gemzar

Active Comparator: B Drug: gemcitabine
1000 mg/m2, IV, days 1, 8 and 15 per cycle, six 28 day cycles
Other Names:
  • LY188011
  • Gemzar

Primary Outcome Measures :
  1. Overall survival [ Time Frame: baseline to the date of death from any cause. ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: baseline to measured progressive disease ]
  2. Progression free survival [ Time Frame: baseline to measured progressive disease ]
  3. Duration of response [ Time Frame: time of response to progressive disease ]
  4. Quality of life [ Time Frame: baseline, each cycle, end of study ]
  5. Toxicity [ Time Frame: every cycle ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Diagnosis of adenocarcinoma of the pancreas.
  • Pretreatment tumor specimen must be available.
  • No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5FU with radiation therapy.
  • Prior radiation allowed.
  • Ability to stop some types of anti-seizure medicines within 14 days of enrollment.

Exclusion Criteria:

  • Endocrine pancreatic tumor or ampullary cancer.
  • Central Nervous System metastases.
  • Inability to swallow tablets.
  • 10% or greater weight loss over the 6 weeks before study entry.

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 identifier (NCT number): NCT00267020

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United States, Texas
For additional information regarding invesigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Dallas, Texas, United States
Sponsors and Collaborators
Eli Lilly and Company
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
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Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00267020     History of Changes
Other Study ID Numbers: 10463
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs