Clinical trial NCT00657137: APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)
Official title: A Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of Patients With HER2/Neu+ Breast Cancer Who Have Failed Trastuzumab and Chemotherapy Including a Taxane
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: HER2/neu positive
locally advanced or metastatic
Lead sponsor: Tragara Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion for patients who will benefit from future treatment with apricoxib.


Eligibility criteria: Inclusion Criteria:

* Females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (HER2/neu+) breast cancer
* Have progressed after treatment with chemotherapy including a taxane and trastuzumab
* Must have measurable disease by RECIST
* ECOG PS of 0,1, or 2
* MUGA scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50%

Exclusion Criteria:

* Radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment
* Evidence of New York Heart Association class III or greater cardiac disease
* History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
* History of congenital QT prolongation
* Concurrent severe or uncontrolled medical disease
* Symptomatic central nervous system metastases
* Pregnant or nursing women
* Hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-FU, sulfonamides, aspirin, or NSAIDs
* Severe renal insufficiency
* History of upper GI bleeding, ulceration, or perforation- Concurrent use of potent CYP3A4 inhibitors and CYP3A4 inducers
* Prior treatment with capecitabine
* Patients on anti-arrhythmic treatment
* Prior lapatinib therapy

Primary outcomes:
measure: To determine the anti-tumor activity of the combination of apricoxib/lapatinib-capecitabine compared with placebo/lapatinib-capecitabine as measured by time to disease progression.
timeFrame: Time to disease progression
Secondary outcomes:
measure: Progression-free survival and safety/tolerability
timeFrame: Time to disease progression
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Berkeley
country: United States
facility: Alta Bates Summit Comprehensive Cancer Center
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Group, LLC
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare
state: California
city: Inland Valleys/Pomona
country: United States
facility: Wilshire Oncology Medical Group Inc
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Olive View
country: United States
facility: Olive View- UCLA Medical Center
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group Inc
state: California
city: San Dimas
country: United States
facility: North America Research Institute
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Ft. Collins
country: United States
facility: Front Range Cancer Specialists
state: Colorado
city: Lake Worth
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center in Orlando
state: Florida
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates
state: Georgia
city: Maryville
country: United States
facility: Warren Billhartz Cancer Center
state: Illinois
city: Normal
country: United States
facility: Mid-Illinois Hematology Oncology Associates
state: Illinois
city: Muncie
country: United States
facility: Medical Consultants PC
state: Indiana
city: Ann Arbor
country: United States
facility: SJMH Cancer Center
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Center Institute
state: Michigan
city: Jackson County
country: United States
facility: Foote Health System
state: Michigan
city: Lansing
country: United States
facility: Bresline Cancer Center at Michigan State University
state: Michigan
city: Livonia
country: United States
facility: St. Mary Mercy Hospital
state: Michigan
city: Port Huron
country: United States
facility: Mercy Hospital
state: Michigan
city: Saginaw
country: United States
facility: St. Mary's of Michigan
state: Michigan
city: Grand Island
country: United States
facility: St. Francis Cancer Treatment Center
state: Nebraska
city: Phillipsburg
country: United States
facility: Warren Hospital
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Sylvania
country: United States
facility: Flower Hospital Cancer Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Corvallis
country: United States
facility: Samaritan Hematology and Oncology Consulting
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center
state: Pennsylvania
city: Upland
country: United States
facility: Associates in Hematology-Oncology PC
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Oncology Hematology Associates
state: South Carolina
city: Knoxville
country: United States
facility: Baptist Regional Cancer Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Jabboury Foundation for Cancer Research Inc
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Healthcare Inc.
state: Vermont
city: Rutland
country: United States
facility: Community Cancer Center at Rutland Regional Medical Center
state: Vermont
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Tragara Pharmaceuticals, Inc.
name: Sara Zaknoen, M.D.
role: STUDY_DIRECTOR
References: