Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Non-Small-Cell Lung Carcinoma Clinical Trial

Official title:

A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112346
• Other study ID #: CA225-100
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2005
• Last updated: October 26, 2015
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: October 2015
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.

• Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva).

• Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.

• Must be able to carry out work of light or sedentary nature (e.g. light house work, office work).

• It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.

Exclusion Criteria:

• Women who are pregnant or breastfeeding.

• Women with a positive pregnancy test on enrollment or prior to study drug administration.

• Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).

• Symptomatic or uncontrolled metastases in the central nervous system (CNS).

• Peripheral neuropathy.

• Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm^3, a platelet count <100,000/mm^3, or a hemoglobin level < 9g/dL.

• Inadequate liver function.

• Inadequate kidney function.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• Cetuximab + platinum + gemcitabine
Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.
• Platinum + Gemcitabine
Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.

Locations

Country	Name	City	State
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Greenfield Park	Quebec
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Moncton	New Brunswick
Canada	Local Institution	Montreal	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Windsor	Ontario
United States	Local Institution	Anchorage	Alaska
United States	Local Institution	Annapolis	Maryland
United States	Local Institution	Armonk	New York
United States	Local Institution	Austell	Georgia
United States	Local Institution	Bakersfield	California
United States	Local Institution	Bismarck	North Dakota
United States	Local Institution	Boynton Beach	Florida
United States	Local Institution	Brooksville	Florida
United States	Local Institution	Charleston	South Carolina
United States	Local Institution	Cincinnati	Ohio
United States	Local Institution	Corona	California
United States	Local Institution	Dallas	Texas
United States	Local Institution	Farmington	New Mexico
United States	Local Institution	Frederick	Maryland
United States	Local Institution	Gastonia	North Carolina
United States	Local Institution	Honolulu	Hawaii
United States	Local Institution	Inverness	Florida
United States	Local Institution	Lakewood	Colorado
United States	Local Institution	Mobile	Alabama
United States	Local Institution	Muncie	Indiana
United States	Local Institution	Oxnard	California
United States	Local Institution	Pembroke Pines	Florida
United States	Local Institution	Plymouth	Massachusetts
United States	Local Institution	Portland	Oregon
United States	Local Institution	Rockville	Maryland
United States	Local Institution	San Diego	California
United States	Local Institution	Skokie	Illinois
United States	Local Institution	Stony Brook	New York
United States	Local Institution	Vancouver	Washington
United States	Local Institution	Whittier	California
United States	Local Institution	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ImClone LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response per treatment arm
Secondary	disease control, symptom response, symptomatic progression, & progression free survival.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm