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

Primary Purpose

Metastatic Renal Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Sunitinib

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring metastatic renal cell carcinoma, sunitinib, schedule 2weeks on/1 week off

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 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

Sites / Locations

Chinese acadamy of medical science cancer institute & hospital
Peking University First Hospital
Beijing Cancer HospitalRecruiting
Sun Yat-sen university cancer center
Cancer Hospital, Fudan University
Tianjin medical university cancer institute & hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sunitinib 50mg/day schedule 4/2

Sunitinib 50mg/day schedule 2/1

Arm Description

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

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

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 March 2017 cut off date

Secondary Outcome Measures

The percentage of patients who can get complete response, partial response.

Full Information

NCT ID

NCT02398552

First Posted

March 20, 2015

Last Updated

February 27, 2016

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT02398552

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

March 2017 (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

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.

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, sunitinib, schedule 2weeks on/1 week off

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sunitinib 50mg/day schedule 4/2

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sunitinib 50mg/day schedule 2/1

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Other Intervention Name(s)

Sutent

Intervention Description

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

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 March 2017 cut off date

Time Frame

2 years

Secondary Outcome Measure Information:

Title

The percentage of patients who can get complete response, partial response.

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

Number of adverse events

Time Frame

1 year

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 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

Central Contact Person:

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

Chuanliang Cui, MD

Phone

0086-10-88196951

1008ccl@163.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

Chinese acadamy of medical science cancer institute & hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Changling Li, MD

Phone

0086-10-67781331

changllss@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Changling Li, MD

Facility Name

Peking University First Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

Individual Site Status

Not yet 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

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chuanliang Cui, MD

Phone

0086-10-88196951

1008ccl@163.com

First Name & Middle Initial & Last Name & Degree

Jun Guo, MD,PHD

Phone

0086-10-88196317

guoj307@126.com

First Name & Middle Initial & Last Name & Degree

Jun Guo, MD,PHD

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

Cancer Hospital, Fudan University

City

Shanghai

State/Province

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

Facility Name

Tianjin medical university cancer institute & hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xin Yao, MD

Phone

0086-22-23340123

yaoxin1969@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Xin Yao, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19487381

Citation

Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Aug 1;27(22):3584-90. doi: 10.1200/JCO.2008.20.1293. Epub 2009 Jun 1.

Results Reference

background

PubMed Identifier

19967539

Citation

Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer RJ. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol. 2010 Jul;66(2):357-71. doi: 10.1007/s00280-009-1170-y. Epub 2009 Dec 5.

Results Reference

background

PubMed Identifier

23113655

Citation

Neri B, Vannini A, Brugia M, Muto A, Rangan S, Rediti M, Tassi R, Cerullo C. Biweekly sunitinib regimen reduces toxicity and retains efficacy in metastatic renal cell carcinoma: a single-center experience with 31 patients. Int J Urol. 2013 May;20(5):478-83. doi: 10.1111/j.1442-2042.2012.03204.x. Epub 2012 Nov 1.

Results Reference

background

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

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