Metastatic Renal Cell Carcinoma
Conditions
Keywords
metastatic renal cell carcinoma, sunitinib, schedule 2weeks on/1 week off
Brief 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.
Detailed description
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.
Interventions
DRUGSunitinib
altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress-free survival (PFS) | 2 years | Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until March 2017 cut off date |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients who can get complete response, partial response. | 2 years |
Other
| Measure | Time frame |
|---|---|
| Number of adverse events | 1 year |
Countries
China
Contacts
Primary ContactChuanliang Cui, MD
Backup ContactJun Guo, MD,PHD
Outcome results
None listed