Clinical trial NCT01109524: Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
Official title: Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Carcinoma
Cancer of the Lung
Non-Small-Cell Lung Carcinoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-04-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.


Eligibility criteria: Inclusion Criteria:

* Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy
* Evaluable or measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

* Uncontrolled Central Nervous System (CNS) metastasis.
* Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
* Concurrent malignancy
* Prior chemotherapy for NSCLC
* Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
* Superior vena cava syndrome contra-indicating hydration
* White Blood Cells (WBC) \< 3,000/mm³
* Absolute neutrophile count (ANC) \< 1,500/mm³
* Platelet \< 100,000/mm³
* Hemoglobin (Hgb) \< 9.0 g/dL
* Total bilirubin \> 1.5 x Upper limit of normal (ULN).
* Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 5.0 x ULN.
* Serum creatinine \>1.25 x ULN and calculated creatinine clearance \<60mL/min

Primary outcomes:
measure: Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
timeFrame: Day 1 up to 30 days after last dose
measure: Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
timeFrame: Day 1 to 30 days after last dose
measure: Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
timeFrame: Day 1 up to 30 days after last dose
measure: Number of Participants With Hematology Laboratory Abnormalities - Treated Population
timeFrame: Day 2 up to 30 days after last dose
measure: Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
timeFrame: Day 1 up to 30 days after last dose
measure: Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
timeFrame: Day 1 up to 30 days after last dose
measure: Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
timeFrame: Day 1 up to 30 days after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Casa Grande
country: United States
facility: Donald W. Hill M.D., P.C.
state: Arizona
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cancer Care Institute
state: California
city: Oakland
country: United States
facility: Northern California Hematology & Oncology
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Ft. Lauderdale
country: United States
facility: Broward Oncology Associates, P.A.
state: Florida
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: Skokie
country: United States
facility: Edward H. Kaplan, MD & Associates
state: Illinois
city: Edina
country: United States
facility: Fairview Southdale Medical Oncology Clinic
state: Minnesota
city: Bismarck
country: United States
facility: Mid Dakota Clinic, Pc
state: North Dakota
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Lubbock
country: United States
facility: University Medical Center
state: Texas
city: Kennewick
country: United States
facility: Columbia Basin Hematology and Oncology
state: Washington
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Grand Falls-Windsor
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Mississauga
country: Canada
facility: The Credit Valley Hospital
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Regional Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre (Regional Cancer Care)
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Rimouski
country: Canada
facility: Centre de sante et de services sociaux de Rimouski-Neigette
state: Quebec
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine (Caimed Center)
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: