A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
A Phase II, Open Label Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
1 other identifier
interventional
58
1 country
9
Brief Summary
The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2007
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2006
CompletedFirst Posted
Study publicly available on registry
October 2, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
October 19, 2010
CompletedMarch 10, 2016
February 1, 2016
2.4 years
September 28, 2006
September 24, 2010
February 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Surviving at 6 Months
The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.
From time of first dose of study drug through 6 months
Secondary Outcomes (12)
Best Overall Tumor Response
From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)
Percentage of Participants With Objective Tumor Response
From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression
Median Progression Free Survival Time
From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression
Median Overall Survival Time
From the first dosing date until death (last reported death was 21 months after first dose).
Median Duration of Response
From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).
- +7 more secondary outcomes
Study Arms (1)
Ixabepilone plus Cetuximab
EXPERIMENTALAll participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
Interventions
Intravenous Infusion (IV), 32 mg/m\^2 every 21 days.
Initial dose of 400 mg/m\^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m\^2 IV over 1 hour.
Eligibility Criteria
You may qualify if:
- Histologic or cytologic diagnosis of pancreatic adenocarcinoma (locally advanced disease that is not surgically resectable, or distant metastatic disease)
- Participants must have measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines
- Participants must not have received prior chemotherapy, immunotherapy or chemoradiotherapy for advanced pancreas cancer
- Karnofsky performance status (KPS) of 70-100
- Adequate hematologic, hepatic and renal function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Pharmlead
Study Sites (9)
Georgetn Univ Lombardi Can Ctr
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
University Of Miami
Miami, Florida, 33136, United States
University Of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Ellis Fischel Cancer Center
Columbia, Missouri, 65203, United States
Cancer Centers Of The Carolinas
Greenville, South Carolina, 29615, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study CA163-116 was completed; however, the combination tested in this trial failed to meet the primary objective to demonstrate a 6-month survival rate greater than 50% in participants with metastatic pancreatic cancer.
Results Point of Contact
- Title
- Name/Official Title: BMS Study Director
- Organization
- Organization: Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2006
First Posted
October 2, 2006
Study Start
January 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 10, 2016
Results First Posted
October 19, 2010
Record last verified: 2016-02