CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00043394
First received: August 8, 2002
Last updated: March 11, 2009
Last verified: March 2009
  Purpose

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


Condition Intervention Phase
Carcinoma, Breast
Drug: 0.04 mg/kg CpG 7909
Drug: Herceptin®
Drug: 0.08 mg/kg CpG 7909
Drug: 0.12 mg/kg CpG 7909
Drug: 0.16 mg/kg CpG 7909
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PF-03512676, ProMune
Drug: Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Other Name: Trastuzumab
Experimental: Cohort 2
0.08 mg/kg CpG 7909
Drug: 0.08 mg/kg CpG 7909
0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Other Name: PF-03512676, ProMune
Drug: Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Other Name: Trastuzumab
Experimental: Cohort 3
0.12 mg/kg CpG 7909 Injection once weekly
Drug: 0.12 mg/kg CpG 7909
0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Other Name: PF-03512676, ProMune
Drug: Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Other Name: Trastuzumab
Experimental: Cohort 4
0.16 mg/kg CpG 7909
Drug: 0.16 mg/kg CpG 7909
0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Other Name: PF-03512676, ProMune
Drug: Herceptin®
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
Other Name: Trastuzumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043394

Locations
United States, California
Pfizer Investigational Site
Berkely, California, United States, 94704
Pfizer Investigational Site
Orange, California, United States, 92868
Pfizer Investigational Site
Palm Springs, California, United States, 92262
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007-2197
United States, Florida
Pfizer Investigational Site
Plantation, Florida, United States, 33324
United States, Michigan
Pfizer Investigational Site
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
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Vermont
Pfizer Investigational Site
Burlington, Vermont, United States, 05401-3456
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00043394     History of Changes
Other Study ID Numbers: C015, A8501021, CO15
Study First Received: August 8, 2002
Last Updated: March 11, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
CpG 7909 subcutaneous injection combination with Herceptin® metastatic breast cancer.

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014