Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01109524
First received: April 22, 2010
Last updated: October 18, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Neoplasms Carcinoma Cancer of the Lung Non-Small-Cell Lung Carcinoma |
Drug: Cetuximab Drug: Cisplatin Drug: Vinorelbine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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) [ Time Frame: Weekly safety assessments during and at the end of each patient's treatment period ] [ Designated as safety issue: Yes ]
- AEs - Adverse events
- SAEs - Serious adverse events
| Enrollment: | 60 |
| Study Start Date: | July 2010 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cetuximab + Cisplatin + Vinorelbine |
Drug: Cetuximab
Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
Other Names:
Drug: Cisplatin
Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
Other Name: Platinol
Drug: Vinorelbine
Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
Other Name: Navelbine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109524
Locations
| United States, Arizona | |
| Donald W. Hill M.D., P.C. | |
| Casa Grande, Arizona, United States, 85122 | |
| United States, California | |
| Beverly Hills Cancer Center | |
| Beverly Hills, California, United States, 90211 | |
| Cancer Care Institute | |
| Los Angeles, California, United States, 90036 | |
| Northern California Hematology & Oncology | |
| Oakland, California, United States, 94609 | |
| Sharp Clinical Oncology Research | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| Broward Oncology Associates, P.A. | |
| Ft. Lauderdale, Florida, United States, 33308 | |
| Elite Research Institute | |
| Miami, Florida, United States, 33125 | |
| United States, Illinois | |
| Edward H. Kaplan, MD & Associates | |
| Skokie, Illinois, United States, 60076 | |
| United States, Minnesota | |
| Fairview Southdale Medical Oncology Clinic | |
| Edina, Minnesota, United States, 55435 | |
| United States, North Dakota | |
| Mid Dakota Clinic, Pc | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Pennsylvania | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Texas | |
| University Medical Center | |
| Lubbock, Texas, United States, 79415 | |
| United States, Washington | |
| Columbia Basin Hematology and Oncology | |
| Kennewick, Washington, United States, 99336 | |
| Canada, New Brunswick | |
| The Moncton Hospital | |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Canada, Newfoundland and Labrador | |
| Local Institution | |
| Grand Falls-Windsor, Newfoundland and Labrador, Canada, A2A 2E2 | |
| Canada, Ontario | |
| The Credit Valley Hospital | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| Sudbury Regional Hospital | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Thunder Bay Regional Health Sciences Centre (Regional Cancer Care) | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Toronto East General Hospital | |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Canada, Quebec | |
| Centre de sante et de services sociaux de Rimouski-Neigette | |
| Rimouski, Quebec, Canada, G5L 5T1 | |
| Puerto Rico | |
| Ponce School of Medicine (Caimed Center) | |
| Ponce, Puerto Rico, 00716 | |
| Fundacion de Investigacion de Diego | |
| San Juan, Puerto Rico, 00927 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Eli Lilly and Company
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01109524 History of Changes |
| Other Study ID Numbers: | CA225-346 |
| Study First Received: | April 22, 2010 |
| Last Updated: | October 18, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Vinorelbine |
Cetuximab Cisplatin Vinblastine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013