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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00267020
First received: December 16, 2005
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Pancreatic Neoplasm
Drug: enzastaurin
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall survival [ Time Frame: baseline to the date of death from any cause. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: baseline, each cycle, end of study ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: December 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  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: NCT00267020

Locations
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
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00267020     History of Changes
Other Study ID Numbers: 10463, H6Q-US-S002
Study First Received: December 16, 2005
Last Updated: October 5, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014