Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
ImClone LLC
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00768131
First received: October 6, 2008
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Drug: Cetuximab
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Disease control [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Every 4 months after subject off-treatment until 1 year after LPLT ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Safety & exploratory biomarker analysis [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: October 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768131

Locations
United States, Arkansas
Local Institution
Little Rock, Arkansas, United States, 72205
United States, California
Local Institution
Long Beach, California, United States, 90813
United States, Florida
Local Institution
Boynton Beach, Florida, United States, 33435
United States, Illinois
Local Institution
Chicago, Illinois, United States, 60612
Local Institution
Skokie, Illinois, United States, 60076
United States, Kansas
Local Institution
Wichita, Kansas, United States, 67214
United States, Kentucky
Local Institution
Louisville, Kentucky, United States, 40207
Local Institution
Mt. Sterling, Kentucky, United States, 40353
United States, Maryland
Local Institution
Annapolis, Maryland, United States, 21401
United States, Michigan
Local Institution
Kalamazoo, Michigan, United States, 49048
United States, New York
Local Institution
Staten Island, New York, United States, 10310
United States, North Carolina
Local Institution
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Local Institution
Portland, Oregon, United States, 97213
United States, Texas
Local Institution
Austin, Texas, United States, 78705
Sponsors and Collaborators
Bristol-Myers Squibb
ImClone LLC
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00768131     History of Changes
Other Study ID Numbers: CA225-322
Study First Received: October 6, 2008
Last Updated: May 4, 2011
Health Authority: United States: Food and Drug Administration
Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Cetuximab
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014