We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723957
First Posted: July 29, 2008
Last Update Posted: March 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
R-Pharm
Results First Submitted: June 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Advanced/Metastatic Non-Small Cell Lung Cancer
Interventions: Drug: Ixabepilone, 32 mg/m^2
Drug: Paclitaxel, 200 mg/m^2
Drug: Carboplatin (area under the concentration curve [AUC] 6)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 260 participants enrolled, 197 were randomized. Among those randomized, 191 received treatment.

Reporting Groups
  Description
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6) Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6) Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles

Participant Flow:   Overall Study
    Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)   Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
STARTED   98 [1]   99 [1] 
COMPLETED   47 [2]   46 [2] 
NOT COMPLETED   51   53 
Adverse event unrelated to study drug                1                4 
Death                3                4 
Disease progression                27                25 
Maximum clinical benefit                4                5 
Investigator decision                1                1 
Study drug toxicity                4                6 
Withdrawal by Subject                7                5 
Reason not analyzed                1                0 
Never received treatment                3                3 
[1] Randomized
[2] Completed 6 cycles of study drug (maximum per protocol)



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6) Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6) Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
Total Total of all reporting groups

Baseline Measures
   Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)   Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   99   197 
Age, Customized [1] 
[Units: Years]
Median (Full Range)
     
Beta III (βIII)-tubulin positive tumors (n=53, 51)   60.0 
 (29.0 to 80.0) 
 60.0 
 (43.0 to 80.0) 
 60.0 
 (29.0 to 80.0) 
βIII-tubulin negative tumors (N=45, 48)   60.0 
 (35.0 to 78.0) 
 60.5 
 (34.0 to 85.0) 
 60.0 
 (34.0 to 85.0) 
[1] Participants with beta III (βIII)-tubulin positive tumors
Gender 
[Units: Participants]
     
Female   72   67   139 
Male   26   32   58 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   30   22   52 
White   68   76   144 
Other   0   1   1 
Number of participants with βIII-tubulin positive and negative tumors 
[Units: Participants]
     
βIII tubulin-positive tumors   53   51   104 
βIII tubulin-negative tumors   45   48   93 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors   [ Time Frame: Randomization to disease progression or death (maximum reached: 14.39 months ) ]

2.  Secondary:   Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors   [ Time Frame: Randomization to disease progression or death (maximum reached: 12.29 months) ]

3.  Secondary:   Progression-free Survival in the Overall Population   [ Time Frame: Randomization to disease progression or death, assessed to 12.29 months ]

4.  Secondary:   Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)   [ Time Frame: At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles ]

5.  Secondary:   Time to Response   [ Time Frame: Randomization to date of first response (PR or CR) ]

6.  Secondary:   Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy   [ Time Frame: Days 1 through 21, continuously ]

7.  Secondary:   Number of Participants With Hematology Laboratory Results of Grade 3 or 4   [ Time Frame: At screening and weekly during 21-day cycle ]

8.  Secondary:   Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results   [ Time Frame: At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond) ]

9.  Secondary:   Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors   [ Time Frame: Randomization to death or last known alive date, up to 31.34 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT00723957     History of Changes
Other Study ID Numbers: CA163-163
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: June 20, 2011
Results First Posted: October 17, 2011
Last Update Posted: March 10, 2016