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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms, Carcinoma, Cancer of the Lung, Non-Small-Cell Lung Carcinoma

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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, PCBismarck, North Dakota  58501
Temple University HospitalPhiladelphia, Pennsylvania  19140
Sharp Clinical Oncology ResearchSan Diego, California  92123
Columbia Basin Hematology and OncologyKennewick, Washington  99336
Fairview Southdale Medical Oncology ClinicEdina, Minnesota  55455
Beverly Hills Cancer CenterBeverly Hills, California  90211
Donald W. Hill M.D., P.C.Casa Grande, Arizona  85122
Cancer Care InstituteLos Angeles, California  90036
Northern California Hematology & OncologyOakland, California  94609
Broward Oncology Associates, P.A.Ft. Lauderdale, Florida  33308
Elite Research InstituteMiami, Florida  33125
Edward H. Kaplan, MD & AssociatesSkokie, Illinois  60076
University Medical CenterLubbock, Texas  79415