AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00219557

Purpose

This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.

Condition	Intervention	Phase
Pancreatic Neoplasms	Drug: Gemcitabine Drug: AG-013736 plus gemcitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combination With Gemcitabine In Patients With Chemotherapy Naive Advanced Pancreatic Cancer Preceded By A Phase 1 Portion

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Axitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine whether the overall survival of the combination of AG 013736 and gemcitabine is superior to that of gemcitabine alone in patients who have advanced pancreatic cancer that has not been previously treated with systemic therapy. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

determine the adverse event profile and dose limiting toxicities for the combination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
evaluate population pharmacokinetics of AG 013736 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
determine the response rate and duration of response in patients who have measurable disease at baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	102
Study Start Date:	July 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Gemcitabine: Active Comparator	Drug: Gemcitabine Standard therapy
AG-013736 plus gemcitabine: Experimental	Drug: AG-013736 plus gemcitabine New drug added to standard therapy

Eligibility

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

Criteria

Inclusion Criteria:

patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
no prior therapy for metastatic disease

Exclusion Criteria:

patients with locally advanced disease who are candidates for radiation therapy.
uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219557

Show 36 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Spano JP, Chodkiewicz C, Maurel J, Wong R, Wasan H, Barone C, Létourneau R, Bajetta E, Pithavala Y, Bycott P, Trask P, Liau K, Ricart AD, Kim S, Rixe O. Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. Lancet. 2008 Jun 21;371(9630):2101-8. Epub 2008 May 29.

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061016
Study First Received:	September 13, 2005
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00219557 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Randomized Phase 2 Study of AG-013736 in Combination with Gemcitabine versus Gemcitabine Alone in Advanced Pancreatic Cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010