| General information |
| Database: | DB00829 |
| Objective: | Thisphase Ib study aimed to establish the feasible everolimus dose given with standarddose etoposide plus cisplatin (EP) for extensivestage smallcell lung cancer (SCLC). |
| Authors: | Besse B, et al |
| Title: | a phase Ib doseescalation study of everolimus combined with cisplatin and etoposide as firstline therapy in patients with extensivestage smallcell lung cancer. |
| Journal: | Ann Oncol. |
| Year: | 2014 |
| PMID: | 24368401 |
| Trial Design |
| Clinical Trial Id: | NCT00466466 |
| Agent: | everolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | smallcell lung cancer |
| Cancer Subtype: | extensive stage small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | everolimus combined with cisplatin + etoposide |
| Study Type: | a phase Ib doseescalation study |
| Key Patients Feature: | adults with treatmentnaive extensivestage SCLC |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | An adaptive Bayesian doseescalation model and investigator opinion were used to identify feasible daily or weekly everolimus doses given with EP; A protocol amendment mandated prophylactic granulocyte colonystimulating factor (GCSF). |
| Primary End Point: | cycle 1 doselimiting toxicity (DLT) rate. |
| Secondary End Point: | NA |
| Patients Number: | 40 |
| Trial Results |
| DLT_MTD: | Cycle 1 DLT rates were 50.0%, 22.2%, and 16.7% in cohorts A, B, and C, respectively. Cycle 1 DLTs were neutropenia (cohorts A and B), febrile neutropenia (all cohorts), and thrombocytopenia (cohorts A and C). |
| Objective Response Rate: | NA |
| Disease Control Rate: | 60%, 78%, and 58% in the nonGCSF daily, nonGCSF weekly, and daily GCSF schedules, respectively. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 22.0 weeks in the GCSF 5mg/day group to 35.1 weeks in the GCSF 2.5mg/day group. |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | most commonly neutropenia and thrombocytopenia |
| Conclusions: | Everolimus 2.5 mgday plus GCSF was the only feasible dose given with standarddose EP in untreated extensivestage SCLC. |