A Phase II Trila of Sunitinib Schedule 4/2 vs. Shedule 2/1 as First Line Therapy in Metastatic Renal Cell Carcinoma.

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital
• Treatments: Sunitinib

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