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

Primary Purpose

Metastatic Renal Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Bevacizumab

Sorafenib

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring Metastatic Renal Cell Carcinoma, Third-line treatment, Sorafenib, Bevacizumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sun Yat-sen university cancer center
Peking University First HospitalRecruiting
Beijing Cancer HospitalRecruiting
Cancer Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bevacizumab plus Sorafenib

Sorafenib

Arm Description

Bevacizumab 5mg/kg Q2w Sorafenib 400mg Bid

Sorafenib 400mg Bid

Outcomes

Primary Outcome Measures

progress-free survival,PFS

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

Secondary Outcome Measures

overall survival,OS

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

Safety: adverse events

adverse events

Full Information

NCT ID

NCT02330783

First Posted

December 29, 2014

Last Updated

May 7, 2017

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT02330783

Brief Title

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

Official Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2014 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Renal Cell Carcinoma

Keywords

Metastatic Renal Cell Carcinoma, Third-line treatment, Sorafenib, Bevacizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab plus Sorafenib

Arm Type

Experimental

Arm Description

Bevacizumab 5mg/kg Q2w Sorafenib 400mg Bid

Arm Title

Sorafenib

Arm Type

Active Comparator

Arm Description

Sorafenib 400mg Bid

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avstin

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Other Intervention Name(s)

Nexavar

Intervention Description

400mg twice daily by oral of each 4-week cycle

Primary Outcome Measure Information:

Title

progress-free survival,PFS

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

overall survival,OS

Description

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

Time Frame

3 years

Title

Safety: adverse events

Description

adverse events

Time Frame

1 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinan Sheng, MD

Phone

0086-10-88196951

doctor_sheng@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Guo, MD,PHD

Phone

0086-10-88196317

guoj307@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Guo, MD,PHD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen university cancer center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fangjian Zhou, MD

Phone

0086-20-87343088

zhoufj@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Fangjian Zhou, MD

Facility Name

Peking University First Hospital

City

Beijing

ZIP/Postal Code

100034

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhisong He, MD

Phone

0086-10-83572211

wyj7074@sohu.com

First Name & Middle Initial & Last Name & Degree

Zhisong He, MD

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinan Sheng, MD

Phone

0086-10-88196951

doctor_sheng@126.com

First Name & Middle Initial & Last Name & Degree

Jun Guo, MD,PHD

First Name & Middle Initial & Last Name & Degree

Xinan Sheng, MD

Facility Name

Cancer Hospital, Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dingwei Ye, MD

Phone

0086-21-64175590

dwye@163.com

First Name & Middle Initial & Last Name & Degree

Dingwei Ye, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

24556040

Citation

Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grunwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96. doi: 10.1016/S1470-2045(14)70030-0. Epub 2014 Feb 17.

Results Reference

background

PubMed Identifier

17255307

Citation

Sosman JA, Puzanov I, Atkins MB. Opportunities and obstacles to combination targeted therapy in renal cell cancer. Clin Cancer Res. 2007 Jan 15;13(2 Pt 2):764s-769s. doi: 10.1158/1078-0432.CCR-06-1975.

Results Reference

background

PubMed Identifier

18669456

Citation

Azad NS, Posadas EM, Kwitkowski VE, Steinberg SM, Jain L, Annunziata CM, Minasian L, Sarosy G, Kotz HL, Premkumar A, Cao L, McNally D, Chow C, Chen HX, Wright JJ, Figg WD, Kohn EC. Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity. J Clin Oncol. 2008 Aug 1;26(22):3709-14. doi: 10.1200/JCO.2007.10.8332. Erratum In: J Clin Oncol. 2008 Sep 10;26(26):4363. Figg, William D [added].

Results Reference

background

PubMed Identifier

23598982

Citation

Pal SK, Vogelzang NJ. Sequential treatment strategies and combination therapy regimens in metastatic renal cell carcinoma. Clin Adv Hematol Oncol. 2013 Mar;11(3):146-55.

Results Reference

background

Links:

URL

http://meetinglibrary.asco.org/content/107093-134

Description

The BEST trial (E2804): A randomized phase II study of VEGF, RAF kinase, and mTOR combination targeted therapy (CTT) with bevacizumab (bev), sorafenib (sor), and temsirolimus (tem) in advanced renal cell carcinoma (RCC)

Learn more about this trial

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

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