Clinical trial NCT00043394: CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Breast
Keywords: CpG 7909 subcutaneous injection combination with Herceptin® metastatic breast cancer.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-08-12
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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®
timeFrame: 24 weeks
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
measure: Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time.
timeFrame: 24 weeks
measure: Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Berkely
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Dearborn
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: West Bloomfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Vermont
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: