| General information |
| Database: | DB00779 |
| Objective: | This investigatorinitiated study explores the safety, maximum tolerated dose, clinical response, and pharmacokinetics of hydroxychloroquine (HCQ) with and without erlotinib in patients with advanced non small cell lung cancer. |
| Authors: | Goldberg SB, et al |
| Title: | a phase I study of erlotinib and hydroxychloroquine in advanced non small cell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2012 |
| PMID: | 22878749 |
| Trial Design |
| Clinical Trial Id: | NCT00977470 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | erlotinib and hydroxychloroquine |
| Study Type: | a phase I study |
| Key Patients Feature: | Patients with prior clinical benefit from an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | hydroxychloroquine versus erlotinib and hydroxychloroquine |
| Treatment Info: | patients were randomized to HCQ or HCQ plus erlotinib in a 3 + 3 doseescalation schema. |
| Primary End Point: | DLT, MDT |
| Secondary End Point: | NA |
| Patients Number: | 27 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 0% in arm A; 5% (95% CI, 1-25) in arm B |
| Disease Control Rate: | 26% (95% CI, 12-49) in arm B |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.8 months (95% CI 0.7, 1.8) in arm A and 2 months (95% CI 1.5, 3.8) in arm B. |
| Median OS A vs. C: | 9 months (95% CI 1.4, 38.5) in arm A and 10.6 months (95% CI 3.6, 14.1) in arm B. |
| Adverse Event(agent arm): | The most commonly observed treatmentrelated AEs were rash (37%), nausea (33%), diarrhea (33%), and fatigue (30%). Vomiting, dyspepsia, anorexia, and dry skin occurred in < 20% of patients. Grade 3 or greater AEs were uncommon and were all considered unrelated to HCQ |
| Conclusions: | HCQ with or without erlotinib was safe and well tolerated. The recommendedphase 2 dose of HCQ was 1000 mg when given in combination with erlotinib 150 mg. |