A Study to Determine Whether EGFR Status by FISH Can Predict Results in Non Small Cell Lung Cancer (NSCLC) Patients Treated With Cetuximab, Carboplatin and Paclitaxel

A Randomized Phase II Trial to Assess the Predictive Value of Increased EGFR Copy Number by FISH in Patients With Advanced / Metastatic NSCLC Treated With Cetuximab and Carboplatin / Paclitaxel

The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel

Study Overview

• Status: Withdrawn
• Conditions: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
• Intervention / Treatment: Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Local Institution
  • California
    • Long Beach, California, United States, 90813
      • Local Institution
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Local Institution
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Local Institution
    • Skokie, Illinois, United States, 60076
      • Local Institution
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Local Institution
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Local Institution
    • Mt. Sterling, Kentucky, United States, 40353
      • Local Institution
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Local Institution
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Local Institution
  • New York
    • Staten Island, New York, United States, 10310
      • Local Institution
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Local Institution
  • Oregon
    • Portland, Oregon, United States, 97213
      • Local Institution
  • Texas
    • Austin, Texas, United States, 78705
      • 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:

• Subjects who present with Stage IV, Stage IIIB NSCLC or recurrent disease following radiation therapy or surgical resection
• No prior chemotherapy or anti-EGFR targeted therapy
• Sufficient tumor material for FISH testing
• Measurable disease (RECIST)
• ECOG performance status 0 or 1

Exclusion Criteria:

• Symptomatic or uncontrolled CNS metastases
• Inadequate hematologic function defined as ANC < 1,500/mm3, platelet count < 100,000/mm3, or a hemoglobin level < 9 g/dl
• Inadequate hepatic function defined as total bilirubin > 1.25 x ULN, AST level > 1.5 x ULN, or alkaline phosphatase > 5.0 x ULN
• Inadequate renal function defined by a serum creatinine level > 1.5 x ULN

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1 FISH (+)	Drug: Cetuximab; Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision; Other Names: Erbitux; BMS-564717; Drug: Paclitaxel; Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum; Drug: Carboplatin; Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
Active Comparator: B1 FISH (+)	Drug: Paclitaxel; Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum; Drug: Carboplatin; Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
Experimental: A2 FISH (-)	Drug: Cetuximab; Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision; Other Names: Erbitux; BMS-564717; Drug: Paclitaxel; Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum; Drug: Carboplatin; Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
Active Comparator: B2 FISH (-)	Drug: Paclitaxel; Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum; Drug: Carboplatin; Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab	Every 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumor response	Every 6 weeks
Disease control	Every 6 weeks
Overall survival (OS)	Every 4 months after subject off-treatment until 1 year after LPLT
Duration of Response	Every 6 weeks
Safety & exploratory biomarker analysis	Every 3 weeks

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: October 6, 2008
• First Submitted That Met QC Criteria: October 6, 2008
• First Posted (Estimate): October 7, 2008

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

• 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; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Carboplatin; Paclitaxel; Cetuximab
• Other Study ID Numbers: CA225-322