Phase 2
Completed N=197
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
Source: ClinicalTrials.gov NCT00723957 ↗Enrolled (actual)
197
Serious AEs
28.8%
Results posted
Oct 2011
Primary outcomePrimary: Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors — 4.27; 4.27 Months — p=0.5735
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors |
4.27; 4.27 | 0.5735 |
| SECONDARY Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors |
5.78; 5.32 | 0.1750 |
| SECONDARY Progression-free Survival in the Overall Population |
5.29; 5.13 | 0.316 |
| SECONDARY Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) |
17.0; 29.4; 26.7; 27.1; 21.4; 28.3 | — |
| SECONDARY Time to Response |
12.1; 6.6; 9.5; 7.0; 12.1; 6.6 | — |
| SECONDARY 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 |
28; 34; 85; 87; 27; 28 | — |
| SECONDARY Number of Participants With Hematology Laboratory Results of Grade 3 or 4 |
31; 15; 54; 51; 14; 1 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results |
1; 0; 0; 0; 0; 1 | — |
| SECONDARY 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 |
10.61; 11.37; 16.92; 9.40; 13.04; 10.15 | — |
Eligibility Criteria
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 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
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.
Data sourced from ClinicalTrials.gov (NCT00723957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.