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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.

Information source: Beijing Cancer Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Renal Cell Carcinoma

Intervention: Sunitinib (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Beijing Cancer Hospital

Official(s) and/or principal investigator(s):
Jun Guo, MD,PHD, Principal Investigator, Affiliation: Beijing Cancer Hospital

Overall contact:
Chuanliang Cui, MD, Phone: 0086-10-88196951, Email: 1008ccl@163.com

Summary

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: progress-free survival (PFS)

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

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

Beijing Cancer Hospital, Beijing, Beijing 100142, China; Recruiting
Chuanliang Cui, MD, Phone: 0086-10-88196951, Email: 1008ccl@163.com
Jun Guo, MD,PHD, Phone: 0086-10-88196317, Email: guoj307@126.com
Jun Guo, MD,PHD, Principal Investigator

Chinese acadamy of medical science cancer institute & hospital, Beijing, Beijing 100021, China; Not yet recruiting
Changling Li, MD, Phone: 0086-10-67781331, Email: changllss@yahoo.com.cn
Changling Li, MD, Principal Investigator

Peking University First Hospital, Beijing, Beijing 100034, China; Not yet recruiting
Zhisong He, MD, Phone: 0086-10-83572211, Email: wyj7074@sohu.com
Zhisong He, MD, Principal Investigator

Sun Yat-sen university cancer center, Guangzhou, Guangdong 510060, China; Not yet recruiting
Fangjian Zhou, MD, Phone: 0086-20-87343088, Email: zhoufj@sysucc.org.cn
Fangjian Zhou, MD, Principal Investigator

Cancer Hospital, Fudan University, Shanghai, Shanghai 200032, China; Not yet recruiting
Dingwei Ye, MD, Phone: 0086-21-64175590, Email: dwye@163.com
Dingwei Ye, MD, Principal Investigator

Tianjin medical university cancer institute & hospital, Tianjin, Tianjin 300060, China; Not yet recruiting
Xin Yao, MD, Phone: 0086-22-23340123, Email: yaoxin1969@yahoo.com.cn
Xin Yao, MD, Principal Investigator

Additional Information

Related publications:

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.

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. Review.

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.

Starting date: March 2015
Last updated: March 24, 2015

Page last updated: August 23, 2015

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