A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer


Tracking Information

Start Date  ICMJEDecember 2008
Estimated Primary Completion DateFebruary 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 12, 2008)		To compare the progression-free survival (PFS) in the ixabepilone plus carboplatin arm to that in the paclitaxel plus carboplatin arm for the subgroup with βIII tubulin positive tumors (βIII tubulin positive subgroup). [ Time Frame: Assessed by tumor measurements (scans) every 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: July 25, 2008)		To compare the progression-free survival (PFS) in the ixabepilone plus carboplatin arm to that in the paclitaxel plus carboplatin arm for the subgroup with βIII tubulin positive tumors (βIII tubulin positive subgroup). [ Time Frame: Assessed by tumor measurements (scans) every 6 weeks ]
Change HistoryComplete list of historical versions of study NCT00723957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: August 12, 2008)
  • Progression free survival rate [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Response rate and the disease control rate [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Time to response and duration of the best response [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Safety analysis [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: July 25, 2008)
  • Progression free survival rate [ Time Frame: 18 weeks ]
  • Overall survival [ Time Frame: throughout the study ]
  • Response rate and the disease control rate [ Time Frame: throughout the study ]
  • Time to response and duration of the best response [ Time Frame: throughout the study ]
  • Safety analysis [ Time Frame: throughout the study ]

Descriptive Information

Brief Title  ICMJEA Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer
Official Title  ICMJEA Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary

The purpose of this study is to determine if Ixabepilone combined with carboplatin is better than paclitaxel combined with carboplatin in a subgroup of patients with non-small cell lung cancer (NSCLC) whose tumors are positive for the βΙII isoform of tubulin

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJEAdvanced/Metastatic Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Ixabepilone + Carboplatin
    Solutions, IV, Ixabepilone 32 mg/m2 + Carboplatin (AUC 6), day 1, every 21 days, 6 cycles
    Other Names:
    • IXEMPRA
    • BMS-247550
  • Drug: Paclitaxel + Carboplatin
    Solutions, IV, Paclitaxel 200 mg/m2 + Carboplatin (AUC 6), day 1, every 21 days, 6 cycles
    Other Names:
    • TAXOL
    • BMS-181339
    • PARAPLATIN
    • BMY-26575
Study Arms / Comparison Groups
  • A: Experimental
    Intervention: Drug: Ixabepilone + Carboplatin
  • B: Active Comparator
    Intervention: Drug: Paclitaxel + Carboplatin

Recruitment Information

Recruitment Status  ICMJERecruiting
Estimated Enrollment  ICMJE260
Estimated Completion DateFebruary 2011
Estimated Primary Completion DateFebruary 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed NSCLC (squamous cell, adenocarcinoma, large cell or bronchoalveolar carcinoma)
  • Stage IIIB with pleural effusion, or stage IV NSCLC, or recurrent disease following surgery and/or radiation therapy
  • Available paraffin embedded tissue to measure the expression levels of βIII tubulin
  • Measurable disease by RECIST guidelines, with at least one target lesion outside any previous radiotherapy field
  • Karnofsky performance status (KPS) of 70-100
  • Life expectancy of at least 3 months
  • Men and women, ages ≥18 years

Exclusion Criteria:

  • Uncontrolled brain metastases
  • Peripheral neuropathy > Grade 1
  • Less than 4 weeks from prior radiation therapy or loco-regional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)
  • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix
  • Known HIV positive
  • Absolute neutrophil count (ANC) <1500 cells mm³
  • Total bilirubin greater than Upper Limit of Normal (ULN) as defined by the Institution (with the exception of elevation due to Gilbert's syndrome)
  • Aspartate transaminase (AST) or alanine transaminase (ALT) > 2.5 x ULN
  • Serum creatine ≥1.5 mg/dL
  • Renal function with a calculated creatinine clearance (CrCl) based on Cockcroft and Gault < 50 mL/min
  • Any prior antineoplastic systemic regimens. Subjects must not initiate any concurrent antineoplastic therapy (i.e. chemotherapy, hormonal therapy, immunotherapy, radiation therapy, herbal regimens or standard of investigational agents for treatment of NSCLC)
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEUnited States,   Argentina,   Australia,   France,   Germany,   Italy,   Korea, Republic of,   Russian Federation,   Spain,   Taiwan

Administrative Information

NCT ID  ICMJENCT00723957
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECA163-163
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb