Efficacy and Safety of Bevacizumab Plus Sorafenib for the Third-line Treatment in Metastatic Renal Cancer Patients

May 7, 2017 updated by: Jun Guo, Peking University Cancer Hospital & Institute

A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus Sorafenib Versus Sorafenib for the Third-line Treatment of Patients With Metastatic Renal Cell Carcinoma

There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with Metastatic renal cell carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Therapies targeting VEGF and mTOR signalling pathways represent standard first-line and second-line treatment options for patients with metastatic renal cell carcinoma. There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.To the best of the investigators knowledge, GOLD study is the first phase 3 trial in the third-line setting after both VEGF-inhibitor and mTOR-inhibitor drugs.From this study,Sorafenib may be option for the third-line treatment.The Best trial demonstrated that Bevacizumab/sorafenib had best efficacy in advance renal cancer canrcinoma and the VEGF/VEGFR co-inhibition strategy may warrant further investigation possibly with more selective VEGFR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with Metastatic renal cell carcinoma.

Study Type

Interventional

Enrollment (Anticipated)

106

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 Locations

  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Principal Investigator:
          • Jun Guo, MD,PHD
        • Sub-Investigator:
          • Xinan Sheng, MD
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Zhisong He, MD
      • 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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Fangjian Zhou, 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 cellcarcinoma is diagnosed histologically or pathologically

    • 1st line treatment of Sunitinib and 2nd line treatment of Everolimus and no more systemic anti-angiogenesis targeted drug therapy
    • Have 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 chemotherapy, 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:

  • 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
    • Patients with evidence of hemorrhagic constitution or a past history of hemorrhage
    • Patients currently receiving renal dialysis
    • Past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment
    • Patients participating in other clinical trials simultaneously
    • Other conditions unsatisfying the inclusion criteria in the investigator's opinions

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
Experimental: Bevacizumab plus Sorafenib
Bevacizumab 5mg/kg Q2w Sorafenib 400mg Bid
Drug: Bevacizumab
5mg/kg by intravenous (IV) infusion every two weeks of each 4-week cycle (dose was based on patient's weight at screening and remained the same throughout study)
Other Names:
  • Avstin
Drug: Sorafenib
400mg twice daily by oral of each 4-week cycle
Other Names:
  • Nexavar
Active Comparator: Sorafenib
Sorafenib 400mg Bid
Drug: Sorafenib
400mg twice daily by oral of each 4-week cycle
Other Names:
  • Nexavar

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 31 December 2017 cut of date
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival,OS
Time Frame: 3 years
Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment until 31 December 2017 cut of date
3 years
Safety: adverse events
Time Frame: 1 years
adverse events
1 years

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

Helpful Links

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

December 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 29, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 5, 2015

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 7, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCH-RCC-141201

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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