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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer
Secondary ID [1] 0 0
CA163-163
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced/Metastatic Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival in the Subgroup of Participants With ßIII-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 (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.
Timepoint [1] 0 0
Randomization to disease progression or death (maximum reached: 14.39 months )
Secondary outcome [1] 0 0
Progression-free Survival in the Subgroup of Participants With ßIII-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.
Timepoint [1] 0 0
Randomization to disease progression or death (maximum reached: 12.29 months)
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Randomization to disease progression or death, assessed to 12.29 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles
Secondary outcome [4] 0 0
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])
Timepoint [4] 0 0
Randomization to date of first response (PR or CR)
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Days 1 through 21, continuously
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
At screening and weekly during 21-day cycle
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)
Secondary outcome [8] 0 0
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 - 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.
Timepoint [8] 0 0
Randomization to death or last known alive date, up to 31.34 months

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Bankstown
Recruitment hospital [2] 0 0
Local Institution - Frankston
Recruitment hospital [3] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
France
State/province [4] 0 0
Poitiers
Country [5] 0 0
France
State/province [5] 0 0
Strasbourg
Country [6] 0 0
Germany
State/province [6] 0 0
Bad Berka
Country [7] 0 0
Germany
State/province [7] 0 0
Grosshansdorf
Country [8] 0 0
Germany
State/province [8] 0 0
Ulm
Country [9] 0 0
Italy
State/province [9] 0 0
Genova
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Sondrio
Country [12] 0 0
Italy
State/province [12] 0 0
Terni
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Gyeonggi-Do
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Chelyabinsk
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Kazan
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Moscow
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Ryazan
Country [19] 0 0
Russian Federation
State/province [19] 0 0
St. Petersburg
Country [20] 0 0
Spain
State/province [20] 0 0
Baracaldo (Vizcaya)
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taichung
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taoyuan Hsien

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
R-Pharm
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00723957
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications