A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00383149

Purpose

The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subject with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied.

Condition	Intervention	Phase
Metastatic Pancreatic Cancer	Drug: Ixabepilone + Cetuximab	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Cetuximab Ixabepilone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Open Label Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Six-month survival rate [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective tumor response rate [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Time to response and safety [ Time Frame: at the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	57
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: Ixabepilone + Cetuximab Intravenous Infusion, IV, Ixabepilone = 32mg/m2 & Cetuximab = 250 mg/m2 (Initial loading dose = 400 mg/m2), Ixabepilone every 21 days & Cetuximab every 7 days. Followed for survival until death or withdrawal from study

Eligibility

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

Criteria

Inclusion Criteria:

Histologic or cytologic diagnosis of pancreatic adenocarcinoma (locally advanced disease that is not surgically resectable, or distant metastatic disease)
Subjects must have measurable disease as per RECIST guidelines
Subjects 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383149

Locations

United States, District of Columbia
Georgetn Univ Lombardi Can Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
University Of Miami
Miami, Florida, United States, 33136
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Michigan
University Of Michigan
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States, 48201
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-116
Study First Received:	September 28, 2006
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00383149 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Epothilones
Pancreatic Neoplasms
Tubulin Modulators
Cetuximab

Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Antimitotic Agents
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Epothilones
Cetuximab
Mitosis Modulators
Endocrine System Diseases
Antimitotic Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Tubulin Modulators
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009