CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

March 11, 2009 updated by: Pfizer

A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkely, California, United States, 94704
        • Pfizer Investigational Site
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92262
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007-2197
        • Pfizer Investigational Site
    • Florida
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Pfizer Investigational Site
      • Dearborn, Michigan, United States, 48126-2641
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site
      • West Bloomfield, Michigan, United States, 48322-3013
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401-3456
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 may have had up to three prior chemotherapy regimens for metastatic disease, which may have been given in combination with Herceptin® and which may have been discontinued due to toxicities. In addition, patients may have had adjuvant chemotherapy.
  • Phase II only: Must have measurable disease by RECIST criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques, or as > 10 mm with spiral CT scan

Exclusion Criteria:

  • Any prior therapy with anthracycline + Herceptin® concurrently
  • 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%
  • Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1
0.04 mg/kg CpG 7909
Drug: 0.04 mg/kg CpG 7909
0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Other Names:
  • PF-03512676, ProMune
Drug: Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Other Names:
  • Trastuzumab
EXPERIMENTAL: Cohort 2
0.08 mg/kg CpG 7909
Drug: Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Other Names:
  • Trastuzumab
Drug: 0.08 mg/kg CpG 7909
0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Other Names:
  • PF-03512676, ProMune
EXPERIMENTAL: Cohort 3
0.12 mg/kg CpG 7909 Injection once weekly
Drug: Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Other Names:
  • Trastuzumab
Drug: 0.12 mg/kg CpG 7909
0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Other Names:
  • PF-03512676, ProMune
EXPERIMENTAL: Cohort 4
0.16 mg/kg CpG 7909
Drug: Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Other Names:
  • Trastuzumab
Drug: 0.16 mg/kg CpG 7909
0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Other Names:
  • PF-03512676, ProMune

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase I: To evaluate the safety and tolerability of several dose levels of CPG 7909 (up to a maximum of 0.16 mg/kg) and to determine the maximum tolerated dose (MTD)* of CPG 7909 in combination with Herceptin®
Time Frame: 24 weeks
24 weeks
Phase II: To evaluate tumor response and safety of CPG 7909 (at the MTD as determined in Phase I) in combination with Herceptin® in patients with metastatic breast cancer.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time.
Time Frame: 24 weeks
24 weeks
Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ACTUAL)

October 1, 2003

Study Completion (ACTUAL)

October 1, 2003

Study Registration Dates

First Submitted

August 8, 2002

First Submitted That Met QC Criteria

August 9, 2002

First Posted (ESTIMATE)

August 12, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C015
  • A8501021, CO15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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