Entry Detail
| General information | |
| Database: | DB00509 |
| Objective: | This study examined the HRQOL of patients with metastatic RCC treated with axitinib, a new targeted therapy that affects the vessels supplying blood to the tumor. |
| Authors: | Trask PC, et al |
| Title: | Healthrelated quality of life during treatment for renal cell carcinoma: results from a phase II study of axitinib. |
| Journal: | Acta Oncol. |
| Year: | 2008 |
| PMID: | 18568482 |
| Trial Design | |
| Clinical Trial Id: | NCT00076011 |
| Agent: | axitinib |
| Target: | Macrophage colonystimulating factor 1 Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | results from a phase II studyof axitinib |
| Key Patients Feature: | Patients with metastatic RCC who had received oneprior cytokinebased therapy (IFNa and/or IL2)were enrolled into the study. Eligibility criteriaincluded written and voluntary informed consent;histologically documented metastatic RCC; failureof one prior cytokinebased therapy due to diseaseprogression or unacceptable treatmentrelated toxicity; at least one target lesion, as defined byResponse Evaluation Criteria in Solid Tumors, thathas not been irradiated; adequate bone marrow, hepatic and renal function documented within 14days prior to treatment; no evidence of preexistinguncontrolled hypertension; and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Axitinib was administered orally twice daily until disease progression or intolerance. |
| Primary End Point: | objective response rate |
| Secondary End Point: | time to progression, overall survival, safety and HRQOL. |
| Patients Number: | 52 |
| Trial Results | |
| DLT_MTD: | NA |
| 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): | Statistically significant baseline posttreatment changes were observed on the role, cognitive and social functioning scales as well as on the nausea and vomiting, pain and diarrhea symptoms. All of the changes were less than onequarter of the category, with diarrhea being the exception at less than half a category, suggesting that the changes as reported by patients were not meaningful. |
| Conclusions: | Treatment of metastatic RCC with axitinib demonstrated acceptable disruption in HRQOL functioning and symptoms when compared to baseline levels. From a patientreported perspective, treatment with axitinib appears to be well tolerated. |