Entry Detail
| General information | |
| Database: | DB00831 |
| Objective: | To determine the maximum tolerated dose (MTD), safety and tolerability of sunitinib plus pemetrexed and cisplatin for advanced solid malignancies. |
| Authors: | Camidge DR, et al |
| Title: | Sunitinib combined with pemetrexed and cisplatin: results of a phase I doseescalation and pharmacokinetic study in patients with advanced solid malignancies, with an expanded cohort in non small cell lung cancer and mesothelioma |
| Journal: | Cancer Chemother Pharmacol. |
| Year: | 2013 |
| PMID: | 23108697 |
| Trial Design | |
| Clinical Trial Id: | NCT00528619 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced solid tumors |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Sunitinib combined with pemetrexed + cisplatin |
| Study Type: | a phase I doseescalation and pharmacokinetic study |
| Key Patients Feature: | patients with advanced solid malignancies, with an expanded cohort in non small cell lung cancer and mesothelioma. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Using a 3 + 3 doseescalation design, patients received oral sunitinib (37.5 or 50 mg) qd on a continuous daily dosing (CDD) schedule or Schedule 2/1 (2 weeks on, 1 week off treatment) plus pemetrexed (400 or 500 mg/m(2) IV) and cisplatin (75 mg/m(2) IV) q3w up to 6 cycles. |
| Primary End Point: | the maximum tolerated dose (MTD), safety and tolerability |
| Secondary End Point: | NA |
| Patients Number: | 20 |
| Trial Results | |
| DLT_MTD: | The MTD was defined as the highest dose at which less than and equal to 1/6 patients experienced a doselimiting toxicity (DLT) during the first 22 days of treatment, with the next dose level above this having at least 2/3 or 2/6 patients who experienced a DLT or the dose level was otherwise deemed inappropriate to pursue based on available data on all toxicities occurring at any point in therapy (taking into account lateonset or cumulative side effects occurring beyond cycle 1).The MTD was further studied in an expansion cohort of 10 non small cell lung cancer (non small cell lung cancer) patients and one mesothelioma patient. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | In patients with advanced solid malignancies, sunitinib was not tolerated at 37.5 mg CDD with standard pemetrexed and cisplatin doses. Dose reductions they were often needed due to cumulative myelosuppression following cycle 1. The MTD showed modest antitumor activity |