Clinical trial NCT00267020: Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neoplasm
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-12-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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 5-fluorouracil (5-FU) 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 (CNS) metastases.
* Inability to swallow tablets.
* 10% or greater weight loss over the 6 weeks before study entry.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization to the date of death from any cause up to 27.7 months
Secondary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)
timeFrame: Randomization to measured progressive disease (PD) up to 19.9 months
measure: Progression Free Survival (PFS)
timeFrame: Randomization to measured PD or death from any cause up to 21.6 months
measure: Duration of Response
timeFrame: Time of response to PD or death from any cause up to 19.9 months
measure: Change in Scores From Baseline (Improved, Stable or Worsened) to End of Study in Functional Assessment of Cancer Therapy Hepatobiliary Version 4 ( FACT-Hep v.4) (Quality of Life (QOL))
timeFrame: Baseline through end of study up to 27.7 months
measure: Relationship of Steady-State Drug Levels to Clinical Outcomes of Overall Survival (OS)
timeFrame: Randomization to date of death from any cause up to 27.7 months
measure: Relationship of Steady-state Drug Levels to Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Disease Control)
timeFrame: Beginning of treatment up to 27.7 months
measure: Carbohydrate Antigen 19-9 (CA 19-9) Concentration in the Blood
timeFrame: Cycles 1 to 6, and post-treatment (up to 27.7 months)
measure: Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) (Toxicity)
timeFrame: Baseline through study completion (Up To 27.7 Months)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: For additional information regarding investigative 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
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Yount S, Cella D, Webster K, Heffernan N, Chang C, Odom L, van Gool R. Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers: the FACT Hepatobiliary Symptom Index. J Pain Symptom Manage. 2002 Jul;24(1):32-44. doi: 10.1016/s0885-3924(02)00422-0.