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
18 Years
N/A
Both
Lung Neoplasms, Carcinoma, Cancer of the Lung, Non-Small-Cell Lung Carcinoma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary safety endpoints will include AEs,SAEs, deaths on-study and within 30 days of last dose, AEs leading to discontinuation, selected AEs of special interest, and laboratory abnormalities (including magnesium)
Outcome Description:
AEs - Adverse events SAEs - Serious adverse events
Outcome Time Frame:
Weekly safety assessments during and at the end of each patient's treatment period
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Institutional Review Board
Study ID:
CA225-346
NCT ID:
NCT01109524
Start Date:
July 2010
Completion Date:
September 2012
Related Keywords:
- Lung Neoplasms
- Carcinoma
- Cancer of the Lung
- Non-Small-Cell Lung Carcinoma
- Neoplasms
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
| Temple University Hospital | Philadelphia, Pennsylvania 19140 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| Columbia Basin Hematology and Oncology | Kennewick, Washington 99336 |
| Fairview Southdale Medical Oncology Clinic | Edina, Minnesota 55455 |
| Beverly Hills Cancer Center | Beverly Hills, California 90211 |
| Donald W. Hill M.D., P.C. | Casa Grande, Arizona 85122 |
| Cancer Care Institute | Los Angeles, California 90036 |
| Northern California Hematology & Oncology | Oakland, California 94609 |
| Broward Oncology Associates, P.A. | Ft. Lauderdale, Florida 33308 |
| Elite Research Institute | Miami, Florida 33125 |
| Edward H. Kaplan, MD & Associates | Skokie, Illinois 60076 |
| University Medical Center | Lubbock, Texas 79415 |
