Clinical trial NCT00652340: APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer
Official title: APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Non Small Cell Lung Cancer
Lead sponsor: Tragara Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 120
Sex: ALL
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 erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with erlotinib alone.


Eligibility criteria: Inclusion Criteria:

* Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion)
* Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible.
* Measurable disease by RECIST
* Greater than or equal to 18 years of age
* ECOG PS of 0 or 1

Exclusion Criteria:

* Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment
* Evidence of NYHA class III or greater cardiac disease
* History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months
* Known HIV infection or AIDS
* Symptomatic CNS metastases
* Pregnant or nursing women
* Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs.
* History of upper GI bleeding, ulceration, or perforation
* Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC
* Previous anti-EGFR kinase therapy

Primary outcomes:
measure: Time to Disease Progression (TDP)
timeFrame: Baseline and every other cycle.
Secondary outcomes:
measure: Overall Survival
timeFrame: Randomization and every cycle
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Dimas
country: United States
state: California
city: Stockton
country: United States
state: California
city: Norwich
country: United States
state: Connecticut
city: Lake North
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Savannah
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Kokomo
country: United States
state: Indiana
city: New Albany
country: United States
state: Indiana
city: Waterloo
country: United States
state: Iowa
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Ann Arbor
country: United States
state: Michigan
city: Jackson
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Livonia
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: St. Joseph
country: United States
state: Michigan
city: Robbinsdale
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Neptune
country: United States
state: New Jersey
city: Elmhurst
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Gastonia
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Canton
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Jefferson City
country: United States
state: Ohio
city: Sylvania
country: United States
state: Ohio
city: Corvallis
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Upland
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Newport News
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Huntington
country: United States
state: West Virginia
city: Morgantown
country: United States
state: West Virginia
Study officials:
affiliation: Tragara Pharmaceuticals, Inc.
name: Tracy Parrott
role: STUDY_DIRECTOR
References:
citation: Gitlitz BJ, Bernstein E, Santos ES, Otterson GA, Milne G, Syto M, Burrows F, Zaknoen S. A randomized, placebo-controlled, multicenter, biomarker-selected, phase 2 study of apricoxib in combination with erlotinib in patients with advanced non-small-cell lung cancer. J Thorac Oncol. 2014 Apr;9(4):577-82. doi: 10.1097/JTO.0000000000000082.