Advanced/Metastatic Non-Small Cell Lung CancerPhase 2NCT00723957
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
A Phase 2 study testing Ixabepilone, 32 mg/m^2, Paclitaxel, 200 mg/m^2 and Carboplatin (area under the concentration curve [AUC] 6) in people with Advanced/Metastatic Non-Small Cell Lung Cancer, run by R-Pharm at 33 sites in 10 countries.
Trial 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 (βIII)-tubulin-positive tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Ixabepilone, 32 mg/m^2, Paclitaxel, 200 mg/m^2 and Carboplatin (area under the concentration curve [AUC] 6)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 33 sitesin 10 countries
- Study dates
- Dec 2008to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 βIII 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
33 sites in 10 countries.
33 sites in 10 countries
Russia7 sites
Local Institution
Chelyabinsk, 454087
Local Institution
Kazan', 420029
Local Institution
Moscow, 115 478
Local Institution
Moscow, 129128
Local Institution
Ryazan, 390011
Local Institution
Saint Petersburg, 194291
Local Institution
Saint Petersburg, 198255
Italy4 sites
Local Institution
Genova, 16132
Local Institution
Milan, 20133
Local Institution
Sondrio, 23100
Local Institution
Terni, 05100
South Korea4 sites
Local Institution
Goyang-si, Gyeonggi-do, 411-769
Local Institution
Seoul, 120-752
Local Institution
Seoul, 135-710
Local Institution
Seoul, 138-736
Argentina3 sites
Local Institution
Buenos Aires, C1426ANZ
Local Institution
Capital Federal, Buenos Aires, 1425
Local Institution
Capital Federal, Buenos Aires, 1437
Australia3 sites
Local Institution
Bankstown, New South Wales, 2200
Local Institution
Frankston, Victoria, 3199
Local Institution
Nedlands, Western Australia, 6009
France3 sites
Local Institution
Poitiers, 86021
Local Institution
Strasbourg, 67085
Local Institution
Strasbourg, 67090
Germany3 sites
Local Institution
Bad Berka, 99437
Local Institution
Großhansdorf, 22927
Local Institution
Ulm, 89081
Taiwan3 sites
Local Institution
Taichung, 407.5
Local Institution
Taipei, 112
Local Institution
Taoyuan Hsien, 333
United States2 sites
Uof Md,Greenebaum Cancer Ctr.
Baltimore, Maryland, 21201
Scripps Cancer Center
La Jolla, California, 90237
About this study
Official title: A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer
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.
- Being tested
- Ixabepilone, 32 mg/m^2, Paclitaxel, 200 mg/m^2, Carboplatin (area under the concentration curve [AUC] 6)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixabepilone, 32 mg/m^2Drug
Also called IXEMPRA, BMS-247550
Intravenous (IV) solutions, ixabepilone, 32 mg/m^2
Paclitaxel, 200 mg/m^2Drug
Also called TAXOL, BMS-181339, PARAPLATIN, BMY-26575
IV solutions, paclitaxel, 200 mg/m^2
Carboplatin (area under the concentration curve [AUC] 6)Drug
Carboplatin (AUC 6) day 1, every 21 days, 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6) | Experimental | Not described Receives: Drug: Ixabepilone, 32 mg/m^2; Drug: Carboplatin (area under the concentration curve [AUC] 6) |
| Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6) | Active comparator | Not described Receives: Drug: Paclitaxel, 200 mg/m^2; Drug: Carboplatin (area under the concentration curve [AUC] 6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to disease progression or death (maximum reached: 14.39 months )
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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])
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Randomization to death or last known alive date, up to 31.34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced/Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723957
- Sponsor's protocol ID
- CA163-163
- Status last verified
- Oct 2020
- First submitted
- 25 Jul 2008
- Last updated
- 28 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.
PubMed 23589560
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00723957
- Acronym / sponsor ID
- CA163-163
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 17 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6) | Experimental | Drug: Ixabepilone, 32 mg/m^2, Drug: Carboplatin (area under the concentration curve [AUC] 6) |
| Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6) | Active comparator | Drug: Paclitaxel, 200 mg/m^2, Drug: Carboplatin (area under the concentration curve [AUC] 6) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 βIII 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ixabepilone, 32 mg/m^2Also: IXEMPRA, BMS-247550Intravenous (IV) solutions, ixabepilone, 32 mg/m^2 | Drug | Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6) |
| Paclitaxel, 200 mg/m^2Also: TAXOL, BMS-181339, PARAPLATIN, BMY-26575IV solutions, paclitaxel, 200 mg/m^2 | Drug | Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6) |
| Carboplatin (area under the concentration curve [AUC] 6)Carboplatin (AUC 6) day 1, every 21 days, 6 cycles | Drug | Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6), Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6) |
Primary outcome
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 )
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.
8 secondary outcomes
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)
Progression-free Survival in the Overall Population
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)
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 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
Time frame: Days 1 through 21, continuously
Number of Participants With Hematology Laboratory Results of Grade 3 or 4
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
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
Time frame: Randomization to death or last known alive date, up to 31.34 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23589560Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
33 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixabepilone, 32 mg/m^2, Paclitaxel, 200 mg/m^2 and Carboplatin (area under the concentration curve [AUC] 6) in people with Advanced/Metastatic Non-Small Cell Lung Cancer, run by R-Pharm at 33 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Russia, Italy, South Korea, Argentina, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00723957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.