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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00723957
Registration number
NCT00723957
Ethics application status
Date submitted
25/07/2008
Date registered
29/07/2008
Date last updated
28/10/2020
Titles & IDs
Public title
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
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Scientific title
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer
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Secondary ID [1]
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CA163-163
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced/Metastatic Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ixabepilone, 32 mg/m^2
Treatment: Drugs - Paclitaxel, 200 mg/m^2
Treatment: Drugs - Carboplatin (area under the concentration curve [AUC] 6)
Experimental: Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6) -
Active Comparator: Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6) -
Treatment: Drugs: Ixabepilone, 32 mg/m^2
Intravenous (IV) solutions, ixabepilone, 32 mg/m^2
Treatment: Drugs: Paclitaxel, 200 mg/m^2
IV solutions, paclitaxel, 200 mg/m^2
Treatment: Drugs: Carboplatin (area under the concentration curve [AUC] 6)
Carboplatin (AUC 6) day 1, every 21 days, 6 cycles
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival in the Subgroup of Participants With ßIII-tubulin Positive Tumors
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Assessment method [1]
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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 (ßIII)-tubulin positive if 50% or more of the tumor cells had a ßIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.
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Timepoint [1]
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Randomization to disease progression or death (maximum reached: 14.39 months )
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Secondary outcome [1]
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Progression-free Survival in the Subgroup of Participants With ßIII-tubulin Negative Tumors
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization to disease progression or death (maximum reached: 12.29 months)
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Secondary outcome [2]
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Progression-free Survival in the Overall Population
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Assessment method [2]
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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.
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Timepoint [2]
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Randomization to disease progression or death, assessed to 12.29 months
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Secondary outcome [3]
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Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)
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Assessment method [3]
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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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Timepoint [3]
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At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles
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Secondary outcome [4]
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Time to Response
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Assessment method [4]
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Time to Response is defined as the time from randomization date until the date of first response (Partial Response [PR] or Complete Response [CR])
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Timepoint [4]
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Randomization to date of first response (PR or CR)
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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Days 1 through 21, continuously
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Secondary outcome [6]
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Number of Participants With Hematology Laboratory Results of Grade 3 or 4
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Assessment method [6]
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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.
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Timepoint [6]
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At screening and weekly during 21-day cycle
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Secondary outcome [7]
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Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results
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Assessment method [7]
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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
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Timepoint [7]
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At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)
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Secondary outcome [8]
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Median Length of Survival in the Overall Population and in the Subgroups of Patients With ßIII-tubulin Positive (ß3T+) and ßIII-tubulin Negative (ß3T-)Tumors
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Assessment method [8]
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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.
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Timepoint [8]
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Randomization to death or last known alive date, up to 31.34 months
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Eligibility
Key inclusion criteria
- Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell,
adenocarcinoma, large cell, or bronchoalveolar carcinoma)
- Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following
surgery with or without radiation therapy
- Available paraffin-embedded tissue to measure the expression levels of ßIII tubulin
- Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1
target lesion situated outside any previous radiotherapy field
- Karnofsky performance status of 70-100
- Life expectancy of at least 3 months
- Men and women, ages 18 years and older
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Uncontrolled brain metastases
- Peripheral neuropathy greater than Grade 1
- Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to
randomization date (less than 1 week from focal/palliative radiotherapy or minor
surgery)
- Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of
the cervix
- Known HIV-positive status
- Absolute neutrophil count lower than 1500 cells mm^3
- Total bilirubin level higher than upper limit of normal (ULN) as defined by the
institution (with the exception of elevation due to Gilbert's syndrome)
- Aspartate transaminase or alanine transaminase level higher than 2.5*ULN
- Serum creatine level of 1.5 mg/dL or higher
- Renal function with a creatinine clearance of less than 50 mL/min (as calculated with
the Cockcroft and Gault equation)
- Any prior antineoplastic systemic regimens.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
260
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Local Institution - Bankstown
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Recruitment hospital [2]
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Local Institution - Frankston
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Recruitment hospital [3]
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Local Institution - Nedlands
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Maryland
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Country [3]
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Argentina
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State/province [3]
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Buenos Aires
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Country [4]
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France
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State/province [4]
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Poitiers
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Country [5]
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France
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State/province [5]
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Strasbourg
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Country [6]
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Germany
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State/province [6]
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Bad Berka
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Country [7]
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Germany
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State/province [7]
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Grosshansdorf
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Country [8]
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Germany
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State/province [8]
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Ulm
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Country [9]
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Italy
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State/province [9]
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Genova
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Italy
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State/province [10]
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Milano
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Italy
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State/province [11]
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Sondrio
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Italy
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State/province [12]
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Terni
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Country [13]
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Korea, Republic of
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State/province [13]
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Gyeonggi-Do
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Country [14]
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Korea, Republic of
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State/province [14]
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Seoul
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Country [15]
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Russian Federation
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State/province [15]
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Chelyabinsk
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Country [16]
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Russian Federation
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State/province [16]
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Kazan
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Country [17]
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Russian Federation
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State/province [17]
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Moscow
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Country [18]
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Russian Federation
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State/province [18]
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Ryazan
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Country [19]
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Russian Federation
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State/province [19]
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St. Petersburg
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Country [20]
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Spain
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State/province [20]
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Baracaldo (Vizcaya)
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Country [21]
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Taiwan
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State/province [21]
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Taichung
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Country [22]
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Taiwan
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State/province [22]
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Taipei
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Country [23]
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Taiwan
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State/province [23]
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Taoyuan Hsien
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
R-Pharm
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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 (ßIII)-tubulin-positive tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00723957
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00723957
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