Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

Metastatic Renal Cell Carcinoma Clinical Trial

— CROSS-J-RCC  

Official title:

Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01481870
• Other study ID #: CROSS-J-RCC
• Secondary ID: UMIN000003040
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 17, 2011
• Last updated: February 21, 2013
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: February 2013
• Source: Yamagata University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free survival and overall survival in a comparative study with interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is one of the treatment options after disease progression. Reversely, when sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy and treatment switched to the other test drug, sorafenib or sunitinib, when disease progression is detected to assess which treatment sequence produces longer progression free survival and offers a better safety profile (causing fewer adverse events). The purpose of this trial is to compare progression free survival of first line sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib followed by sunitinib.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age: 20-80 years old, both inclusive

• ECOG performance status of 0, 1, or 2

• MSKCC risk of favorable or intermediate

• Histologically confirmed renal cell carcinoma

• No ischemic heart disease

• Laboratory findings meet the following criteria:

1. Respiratory function: %VC, 80% and FEV1.0,70%

2. Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3

3. Clinical chemistry: GOT and GPT within the normal range of each medical institution; total bilirubin <1.5 x ULN

4. Serum creatinin <2.0mg/dl, blood urea nitrogen (BUN) <25mg/dl

5. Echocardiographic estimation of left ventricular ejection fraction is higher than the lower limit of reference range of each medical institution.

Exclusion Criteria:

• History of any other malignancy

• Central nervous system metastases. However, patients who remain asymptomatic, have no new or enlarging lesion in the CNS within 6 months of enrollment in this study, and require no corticosteroids may be enrolled.

• History of cardiac infarction, unstable angina, congestive heart failure, or symptomatic peripheral vascular disease within 12 months of enrollment

• History of cerebrovascular disorder including transient ischemic attack (TIA)

• Pregnancy or possible pregnancy at any time during the study

• Ongoing grade 2 adverse event prior treatment

• Prior treatment with any anticancer therapy including cytokine therapy such as interferon-alpha and interleukin-2

• Prior treatment with mTOR inhibitor

• Prior treatment with sunitinib or sorafenib

• Treatment with an test drug in a clinical research within 4 weeks of enrollment in this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• Sorafenib-sunitinib
sorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed
• Sunitinib-sorafenib
sunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed

Locations

Country	Name	City	State
Japan	Yamagata University Faculty of Medicine	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Yamagata University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Tomita Y, Shinohara N, Yuasa T, Fujimoto H, Niwakawa M, Mugiya S, Miki T, Uemura H, Nonomura N, Takahashi M, Hasegawa Y, Agata N, Houk B, Naito S, Akaza H. Overall survival and updated results from a phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma. Jpn J Clin Oncol. 2010 Dec;40(12):1166-72. doi: 10.1093/jjco/hyq146. Epub 2010 Aug 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival in first-line treatment	From date of randomization until the date of first documented progression of the first line treatment or date of death from any cause, whichever came first, assessed up to 36 months.	Time of progression in first line treatment	No
Secondary	Total progression free survival (PFS) in first-line and second-line treatments	From date of randomization until the date of first documented progression of the second line treatment or date of death from any cause, whichever came first, assessed up to 36 months.	Time of progression in second line treatment	No

External Links

•   UMIN Clinical Trial Registry