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This study has been withdrawn prior to enrollment.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

October 6, 2008
May 4, 2011
October 2008
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00768131 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • 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
  • Experimental: A1 FISH (+)
    Interventions:
    • Drug: Cetuximab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Active Comparator: B1 FISH (+)
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Experimental: A2 FISH (-)
    Interventions:
    • Drug: Cetuximab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Active Comparator: B2 FISH (-)
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
260
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00768131
CA225-322
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
ImClone LLC
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP