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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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)
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
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
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
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
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
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
Sex
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
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
260
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00723957