Phase 2
N=84
A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00113516 ↗Enrolled (actual)
84
Serious AEs
38.7%
Results posted
May 2010
Primary outcome: Primary: Proportion of Subjects Surviving at One Year — 0.405 proportion
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carboplatin (Drug); paclitaxel (Drug); sunitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Surviving at One Year |
0.405 | — |
| SECONDARY Progression-free Survival (PFS) |
23.1 | — |
| SECONDARY Time to Tumor Progression (TTP) |
23.6 | — |
| SECONDARY Duration of Response (DR) |
27.3 | — |
| SECONDARY Number of Subjects With Overall Confirmed Objective Disease Response |
23 | — |
| SECONDARY Overall Survival (OS) |
10.4 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of Sunitinib |
57.69; 50.88; 41.55; 38.57 | — |
| SECONDARY Ctrough of SU-012662 (Sunitinib's Metabolite) |
27.54; 23.47; 18.37; 15.67 | — |
| SECONDARY Ctrough of Total Drug (Sunitinib + SU-012662) |
85.23; 74.35; 59.92; 54.24 | — |
| SECONDARY Dose-Corrected Ctrough of Sunitinib |
64.10; 59.85; 49.59; 54.51 | — |
| SECONDARY Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) |
27.90; 27.37; 20.64; 22.29 | — |
| SECONDARY Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) |
92.00; 87.22; 70.24; 76.80 | — |
| SECONDARY Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline |
30382.83 | — |
| SECONDARY VEGFR3 Ratio to Baseline at Each Time Point |
0.39; 0.74; 0.36; 0.70; 0.31; 0.31 | — |
| SECONDARY VEGF-C Concentration at Baseline |
793.19 | — |
| SECONDARY VEGF-C Ratio to Baseline at Each Time Point |
0.81; 0.90; 0.91; 1.00; 0.91; 0.89 | — |
| SECONDARY Soluble E-Selectin at Baseline |
27.06 | — |
| SECONDARY Soluble E-Selectin Ratio to Baseline at Each Time Point |
0.83; 0.89; 0.77; 0.81; 0.69; 0.76 | — |
| SECONDARY VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) |
21660.00; 27740.00 | 0.474 |
| SECONDARY VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) |
0.34; 0.35; 0.75; 0.84; 0.32; 0.38 | 0.836 |
| SECONDARY VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) |
704.80; 766.45 | 0.305 |
| SECONDARY VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) |
0.73; 0.81; 0.87; 0.85; 0.89; 0.69 | 0.738 |
| SECONDARY Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) |
26.40; 27.40 | 0.537 |
| SECONDARY Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) |
0.84; 0.84; 0.84; 0.76; 0.86; 0.64 | 0.813 |
| SECONDARY Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline |
13.1; 10.3; 15.8; 10.3; 22.5; 11.1 | 0.6782 |
| SECONDARY Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline |
16.1; 10.1; 12.4; 11.0; 13.1; 16.1 | 0.5070 |
| SECONDARY Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline |
11.1; 11.0; 11.0; 10.1; 11.0; 16.1 | 0.5277 |
| SECONDARY Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline |
15.8; 11.0; 15.8; 12.4; 30.8; 11.1 | 0.7824 |
| SECONDARY Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline |
16.1; 10.3; 15.8; 11.0; 13.1; 16.1 | 0.5215 |
| SECONDARY Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline |
11.1; 12.4; 11.0; 10.1; 11.0; 16.1 | 0.6682 |
| SECONDARY Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline |
8.7; 6.1; 14.7; 7.1; 13.7; 8.8 | 0.4768 |
| SECONDARY Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline |
8.5; 5.2; 8.5; 8.8; 9.7; 12.7 | 0.4269 |
| SECONDARY Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline |
6.5; 8.0; 8.7; 6.5; 11.2; 8.5 | 0.7660 |
| SECONDARY Immunohistochemical Staining of Paraffin Embedded Tumor Tissue |
— | — |
| SECONDARY Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib |
— | — |
| SECONDARY Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) |
-1.54; -9.13; -2.62; -9.13; 0.60; -2.50 | — |
| SECONDARY Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) |
3.40; 4.80; 4.30; 1.59; -1.59; 4.94 | — |
Summary
The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).
Eligibility Criteria
Inclusion Criteria
- Histologically proven NSCLC
- Stage IIIB (locally advanced with malignant effusion) or Stage IV disease
- No prior therapy for NSCLC
- Evidence of unidimensionally measurable disease
Exclusion Criteria
- Previous treatment with systemic chemotherapy for lung cancer
- History of or known brain metastases
- NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
- Evidence of hemoptysis within 4 weeks of starting study treatment
- Serious acute or chronic illness or recent history of significant cardiac abnormality
- Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of EGFR and PDGFR
Data sourced from ClinicalTrials.gov (NCT00113516). 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.