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

February 27, 2016 updated by: Jun Guo, Peking University Cancer Hospital & Institute

A Randomized Phase II Trila of Sunitinib Four-weeks on/Two-weeks Off Versus Two-weeks on/One-week Off as First Line Therapy in Metastatic Renal Cell Carcinoma.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chuanliang Cui, MD
  • Phone Number: 0086-10-88196951
  • Email: 1008ccl@163.com

Study Contact Backup

  • Name: Jun Guo, MD,PHD
  • Phone Number: 0086-10-88196317
  • Email: guoj307@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun Guo, MD,PHD
      • Beijing, Beijing, China, 100034
        • Not yet recruiting
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Zhisong He, MD
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Chinese acadamy of medical science cancer institute & hospital
        • Contact:
        • Principal Investigator:
          • Changling Li, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Fangjian Zhou, MD
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Cancer Hospital, FuDan University
        • Contact:
          • Dingwei Ye, MD
          • Phone Number: 0086-21-64175590
          • Email: dwye@163.com
        • Principal Investigator:
          • Dingwei Ye, MD
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
        • Principal Investigator:
          • Xin Yao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sunitinib 50mg/day schedule 4/2
Sunitinib 50mg/day 4 weeks on/2 weeks off per 6 weeks till disease progression or intolerable toxicity.
Drug: Sunitinib
altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.
Other Names:
  • Sutent
Experimental: Sunitinib 50mg/day schedule 2/1
Sunitinib 50mg/day 2 weeks on/1 week off per 6 weeks till disease progression or intolerable toxicity.
Drug: Sunitinib
altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.
Other Names:
  • Sutent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progress-free survival (PFS)
Time Frame: 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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage of patients who can get complete response, partial response.
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Jun Guo, MD,PHD, Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 27, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCH-RCC-150212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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