Entry Detail
| General information | |
| Database: | DB00468 |
| Objective: | The objective of this study was to investigate the efficacy of antiangiogenic therapy in combination with cytotoxic chemotherapy in clinically aggressive RCC. |
| Authors: | Michaelson MD, et al |
| Title: | Phase 2 trial of sunitinib and gemcitabine in patients with sarcomatoid and/or poorrisk metastatic renal cell carcinoma. |
| Journal: | Cancer. |
| Year: | 2015 |
| PMID: | 26058385 |
| Trial Design | |
| Clinical Trial Id: | NCT01164228 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | sunitinib + gemcitabine |
| Study Type: | a phase II, openlabel, singlearm study |
| Key Patients Feature: | Eligible patients hadhistologically documented metastatic RCC with anysarcomatoid histology or poorrisk features. This wasdefined as having 3 or more of the following characteristics: ECOG performance status > 1, lactate dehydrogenase level greater than 1.5 times the institutionalupper limit of normal, hemoglobin level less than theinstitutional lotheyr limit of normal, corrected serumcalcium level > 10 mg/dL, 2 or more sites of metastatic disease, and time from the initial diagnosis to evidence of metastatic disease 12 months. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | All patients received treatment with gemcitabine (1000 mg/m2 intravenously on days 1 and 8 of every 21day cycle) and sunitinib (37.5 mg orally daily for 14 consecutive days followed by 7 days off treatment). |
| Primary End Point: | the objective response rate (ORR). |
| Secondary End Point: | the time to progression (TTP), overall survival (OS), safety, and biomarker correlatives. |
| Patients Number: | 39 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | The ORR was 26% for patients with sarcomatoid RCC and 24% for patients with poorrisk RCC. |
| Disease Control Rate: | NA |
| Median Time to Progression: | 5 months for patients with sarcomatoid RCC; 5.5 months for patients with poorrisk disease |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 10 months for patients with sarcomatoid RCC; 15 months for patients with poorrisk disease |
| Adverse Event(agent arm): | The most common grade 3 or higher treatmentrelated adverse events included neutropenia (n 5 20), anemia (n 5 10), and fatigue (n 5 7). |
| Conclusions: | These results suggest that antiangiogenic therapy and cytotoxic chemotherapy are an active and welltolerated combination for patients with aggressive RCC. The combination may be more efficacious than either therapy alone and is currently under further investigation. |