Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00031278

Purpose

The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer.

RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.

SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.

Condition	Intervention	Phase
Carcinoma, Metastatic Breast	Drug: CPG 7909 Drug: Herceptin®	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Open Label, Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin® In Patients With Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Phase I: To evaluate the safety, tolerability and and MTD of several dose levels of CPG 7909 of CPG 7909 in combination with the standard Herceptin® treatment in patients with metastatic breast cancer [ Designated as safety issue: Yes ]
Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer [ Designated as safety issue: No ]

Secondary Outcome Measures:

Phase I: To evaluate tumor response, duration of response, time to disease progression, and survival time [ Designated as safety issue: No ]
Phase II: To evaluate duration of response, time to disease progression, and survival time [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	October 2001
Study Completion Date:	June 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Experimental 0.01 mg/kg CPG 7909 plus Herceptin®	Drug: CPG 7909 Each 0.01 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks. Drug: Herceptin® Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Cohort 2: Experimental 0.04 mg/kg CPG 7909 plus Herceptin®	Drug: CPG 7909 Each 0.04 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks. Drug: Herceptin® Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Cohort 3: Experimental 0.16 mg/kg CPG 7909 plus Herceptin®	Drug: CPG 7909 Each 0.16 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks. Drug: Herceptin® Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Cohort 4: Experimental 0.32 mg/kg CPG 7909 plus Herceptin®	Drug: CPG 7909 Each 0.32 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks. Drug: Herceptin® Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert

Detailed Description:

Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.

Eligibility

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

Criteria

INCLUSION CRITERIA Inclusion Criteria

Histologically confirmed breast cancer with metastases.
Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry.
Patients must be candidates for single agent Herceptin treatment according to the Herceptin® label.

Exclusion Criteria

Any prior therapy with anthracycline + Herceptin®.
Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction < 50%.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031278

Locations

United States, Connecticut
Univ. of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
Cancer Research Network, Inc.
Plantation, Florida, United States, 33324
United States, Maryland
Greenebaum Cancer Center at Univ. of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Comprehensive Cancer Center, University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Cancer Center at Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, Pennsylvania
Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
Pittsburgh, Pennsylvania, United States, 15213
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401

Sponsors and Collaborators

Pfizer

Investigators

Principal Investigator:

Harold Burstein, M.D., Ph.D.

Dana-Farber Cancer Institute

More Information

Additional Information:

Click here for more information on the study sponsor This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	C005, C005, A8501020
Study First Received:	February 28, 2002
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00031278 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Metastatic
Breast
Cancer
immunotherapy
CPG 7909

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Skin Diseases
Antineoplastic Agents
Breast Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplastic Processes

Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Trastuzumab
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009