CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00043394
First received: August 8, 2002
Last updated: March 11, 2009
Last verified: March 2009
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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:
Genetics Home Reference related topics:
breast 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 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
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 May 16, 2013