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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sunitinib 50mg/day schedule 4/2

Sunitinib 50mg/day 4 weeks on/2 weeks off per 6 weeks till disease progression or intolerable toxicity.

Group Type ACTIVE_COMPARATOR

Sunitinib

Intervention Type DRUG

altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.

Sunitinib 50mg/day schedule 2/1

Sunitinib 50mg/day 2 weeks on/1 week off per 6 weeks till disease progression or intolerable toxicity.

Group Type EXPERIMENTAL

Sunitinib

Intervention Type DRUG

altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.

Interventions

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Sunitinib

altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.

Intervention Type DRUG

Other Intervention Names

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Sutent

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jun Guo

Director of department of renal cancer and melanoma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Guo, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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