A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas - Full Text View

Sponsor:	Pfizer
Collaborator:	University of Pennsylvania
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00711191

Purpose

This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence of clinical anti-tumor activity will be sought.

Condition	Intervention	Phase
Pancreatic Neoplasm	Biological: monoclonal antibody Drug: chemotherapy	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Dose Escalation Open Label Study Of CP-870,893 In Combination With Gemcitabine In Patients With Chemotherapy-Naïve Surgically Incurable Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Pancrelipase Gemcitabine Gemcitabine hydrochloride Ultrase Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

safety, tolerability, maximum tolerated dose and recommended phase 2 dose of CP-870,893 in patients with advanced pancreas cancer (phase 1) [ Time Frame: first chemotherapy cycle (28 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

monitor changes in expression of B-lymphocyte activation markers (phase 1 expansion cohort) [ Time Frame: days 1-5 of 1st chemotherapy cycle ] [ Designated as safety issue: No ]
monitor changes in measured concentrations of serum cytokines following administration of CP-870,893 (phase 1) [ Time Frame: days 1 and 3 of chemotherapy cycle ] [ Designated as safety issue: Yes ]
exploration of relationship between exposure to CP-870,893 and clinical response [ Time Frame: end of study ] [ Designated as safety issue: No ]
tumor response (RECIST radiographic and PET-CT) [ Time Frame: following every even-numbered cycle and 4-6 wk following initial response ] [ Designated as safety issue: No ]
characterize single-dose pharmacokinetics of CP-870,893 in this patient population (phase 1) [ Time Frame: days 3 and 4 of chemotherapy cycle ] [ Designated as safety issue: No ]
assessment of progression-free survival and time to progression [ Time Frame: monthly until death or 7.5 mo. following treatment of last patient ] [ Designated as safety issue: No ]
assessment of overall survival [ Time Frame: monthly until death or 7.5 mo. following treatment of last patient ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	June 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single arm: Experimental	Biological: monoclonal antibody CP-870,893 IV on day 3 of 4-wk cycles Drug: chemotherapy gemcitabine 1000 mg/m2 IV qWk x3 of 4-wk cycles

Eligibility

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

Criteria

Inclusion Criteria:

1st-line surgically incurable cancer of the pancreas
ECOG(Eastern Cooperative Oncology Group) performance status 0-1

Exclusion Criteria:

Previous systemic therapy for pancreas cancer
History of cancer-associated blood clots
History of autoimmune disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711191

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Locations

United States, Indiana
Pfizer Investigational Site	Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
Pfizer Investigational Site	Recruiting
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Pfizer

University of Pennsylvania

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5021005
Study First Received:	June 26, 2008
Last Updated:	February 6, 2010
ClinicalTrials.gov Identifier:	NCT00711191 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

pancreas cancer,
cancer of the pancreas,
gemcitabine,

chemotherapy,
monoclonal antibody,
immunotherapy; CD40

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Antibodies, Monoclonal
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Immunoglobulins

Endocrine Gland Neoplasms
Digestive System Neoplasms
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Antibodies
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases

ClinicalTrials.gov processed this record on February 08, 2010