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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small-Cell Lung Carcinoma
• Intervention / Treatment: Drug: Cetuximab + platinum + gemcitabine; Drug: Platinum + Gemcitabine

• Study Type: Interventional
• Enrollment: 120
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A	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.; Other Names: Erbitux
Active Comparator: B	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
tumor response per treatment arm

Secondary Outcome Measures

Outcome Measure
disease control, symptom response, symptomatic progression, & progression free survival.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: June 1, 2005
• First Submitted That Met QC Criteria: June 1, 2005
• First Posted (Estimate): June 2, 2005

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 26, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Non-Small Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Gemcitabine; Cetuximab
• Other Study ID Numbers: CA225-100