The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Intravenous (IV) solutions, ixabepilone, 32 mg/m\^2
IV solutions, paclitaxel, 200 mg/m\^2
Carboplatin (AUC 6) day 1, every 21 days, 6 cycles
Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.
Time frame: Randomization to disease progression or death (maximum reached: 14.39 months )
Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.
Time frame: Randomization to disease progression or death (maximum reached: 12.29 months)
Progression-free Survival in the Overall Population
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.
Time frame: Randomization to disease progression or death, assessed to 12.29 months
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)
Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
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Scripps Cancer Center
La Jolla, California, United States
Uof Md,Greenebaum Cancer Ctr.
Baltimore, Maryland, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Buenos Aires, Argentina
Local Institution
Bankstown, New South Wales, Australia
Local Institution
Frankston, Victoria, Australia
Local Institution
Nedlands, Western Australia, Australia
Local Institution
Poitiers, France
Local Institution
Strasbourg, France
...and 23 more locations
Time frame: At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles
Time to Response
Time to Response is defined as the time from randomization date until the date of first response (Partial Response \[PR\] or Complete Response \[CR\])
Time frame: Randomization to date of first response (PR or CR)
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
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.
Time frame: Days 1 through 21, continuously
Number of Participants With Hematology Laboratory Results of Grade 3 or 4
LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: \<LLN to 3.0\*10\^9/L, Grade 2:\<3.0 to 2.0\*10\^9/L, Grade 3: \<2.0 to 1.0\*10\^9/L, Grade 4: \<1.0\*10\^9/L; Neutrophils (neutropenia) Grade 1: \<LLN to 1.5\*10\^9/L, Grade 2: \<1.5 to 1.0\*10\^9/L, Grade 3: \<1.0 to 0.5\*10\^9/L, Grade 4: \<0.5\*10\^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0\*10\^9/L, Grade 2: \<75.0 to 50.0\*10\^9/L, Grade 3: \<50.0 to 25.0\*10\^9/L, Grade 4:\<25.0 to 10\^9/L; Hemoglobin (anemia) Grade 1: \<LLN to 10.0 g/dL, Grade 2: \<10.0 to 8.0 g/dL, Grade 3: \<8.0 to 6.5 g/dL, Grade 4: \<6.5 g/dL.
Time frame: At screening and weekly during 21-day cycle
Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results
ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:\>ULN to 2.5\*ULN, Gr 2: \>2.5 to 5.0\*ULN, Gr 3: \>5.0 to 20.0\*ULN, Gr 4: \>20.0\*ULN; Aspartate aminotransferase (AST) Gr 1: \>ULN to 2.5\*ULN, Gr 2: \>2.5 to 5.0\*ULN, Gr 3: \>5.0 to 20.0\*ULN, Gr 4: \>20.0\*ULN
Time frame: At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)
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
Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.
Time frame: Randomization to death or last known alive date, up to 31.34 months