Entry Detail
| General information | |
| Database: | DB00832 |
| Objective: | Thisphase I study assessed the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, and preliminary antitumor effects of sunitinib combined with modified FOLFOX6 (mFOLFOX6). |
| Authors: | Leong S, et al |
| Title: | a phase I study of sunitinib combined with modified FOLFOX6 in patients with advanced solid tumors. |
| Journal: | Cancer Chemother Pharmacol. |
| Year: | 2012 |
| PMID: | 22623210 |
| Trial Design | |
| Clinical Trial Id: | NA |
| 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 modified FOLFOX6 |
| Study Type: | a phase I study |
| Key Patients Feature: | Patients with histologically or cytologically documented solid malignancies not amenable to treatment with curative intent were eligible. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received mFOLFOX6 in 2week cycles with escalating sunitinib doses (25, 37.5, and 50 mg/day) on three schedules: 2 weeks on, 2 weeks off (2/2); 4 weeks on, 2 weeks off (4/2); or continuous daily dosing (CDD). Patients received up to 8 treatment cycles (Schedule 2/2 and CDD schedule) or 6 cycles (Schedule 4/2). An expansion cohort enrolled patients with metastatic colorectal cancer at the Schedule 2/2 MTD. |
| Primary End Point: | the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, and preliminary antitumor effects |
| Secondary End Point: | NA |
| Patients Number: | 43 |
| Trial Results | |
| DLT_MTD: | The MTD was defined as the dose level at which no more than 1/6 patients in a cohort experienced doselimiting toxicities (DLTs).DLTs were defined as the following AEs occurring during the first two cycles (4week cycles) on the 2/2 and CDD schedules, and during the first three cycles (6week cycles) on Schedule 4/2: grade 4 neutropenia/thrombocytopenia lasting for more than and equal to 7 days, febrile neutropenia, neutropenic infection or grade more than and equal to 3 thrombocytopenia with bleeding, grade more than and equal to 3 nonhematologic AEs lasting more than and equal to 7 days, or nausea/vomiting or diarrhea if persistent at grade more than and equal to 3 despite maximal medical intervention. |
| 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: | Sunitinib combined with mFOLFOX6 had acceptable tolerability. The MTDs they were sunitinib 50 mgday on Schedule 22 and 25 mgday on the CDD schedule. A MTD for Schedule 42 was not established. |