a phase ii trila of sunitinib schedule 4/2 vs. shedule 2/1 as first line therapy in metastatic renal cell carcinoma.

Conditions: Metastatic Renal Cell Carcinoma

Summary: sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule was reported with a high rate of dose reduction and dose discontinuation because of the safety profile. so investigators conducte this randomized, multi-center phase ii study to determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could provide the same efficacy in terms of progression-free survival, objective response, and overall survival, while reducing drug-related toxicity.

sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule was reported with a high rate of dose reduction and dose discontinuation because of the safety profile. sunitinib 50mg/day on schedule 2/1 (2 weeks on treatment, 1 weeks off) was reported to be associated with significantly decrease toxicities in patients who initially experienced grade 3 or greater toxicity on the schedule 4/2 and could extend treatment duration considerably. through this research, we would like to explore whether the schedule 2/1 of sunitinib 50 mg/day as first line therapy could provide the same efficacy as standard schedule 4/2 in terms of progression-free survival, objective response, and overall survival, while reducing drug-related toxicity in metastatic renal cell carcinoma patients.

Eligibility criteria:
inclusion criteria: * age≥18 years, ≤75 years, male or female * advanced renal cell carcinoma is diagnosed histologically or pathologically * treatment naive at diagnosed * at least one measurable tumor lesion (response evaluation criteria in solid tumors) * eastern cooperative oncology group（ecog) performance scale is 0 or 1 * the expected life span is ≥12 weeks * no contraindications for targeted therapy, with enough liver function and renal function and normal ecg recording peripheral hemogram: neutrophil≥1.5×109/l, plt≥100×109/l, hgb≥90g/l renal function: serum creatinine≤1.5 folds the upper limit of normal (uln) for patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 uln, for patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 uln * the patients participate voluntarily and have signed the informed consent form exclusion criteria: * patients who have received any systemic therapy including targeted therapy,immunotherapy,chemotherapy etc at diagnosed. * pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures * patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds * past history of serious heart diseases, including: cardiac function classification ≥nyha class ii, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension * patients with a history of hiv infection or active phase of chronic hepatitis b/c * negative imaging examination result 4 weeks prior to enrollment) * epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs) * a history of allogeneic organ transplantation

Keywords: metastatic renal cell carcinoma sunitinib schedule 2weeks on/1 week off