Phase II Randomized Comparative Study of Sequential Alternating Therapy with Interferon and Molecular-Targeted Drug for Advanced Renal Cell Carcinoma

UMIN ID: UMIN000001994

Registered date:21/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced Renal Cell Carcinoma
• Date of first enrollment: 2009/08/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Sumiferon 6 million units will be subcutaneously administered three times a week, and treatment will be continued. Judgment for treatment efficacy will be made at least after 12-week treatment. At the time when PD is shown by judgment for treatment efficacy, subjects will be transferred to the secondary treatment. As the secondary treatment, Nexavar 400 mg will be orally administered twice daily every day until PD is shown.
SUTENT 50 mg will be orally administered once daily for 4 weeks and then treatment will be withdrawn for 2 weeks. A total of 6 weeks is 1 course, and subjects will be transferred to the secondary treatment at the time when PD is shown. As the secondary treatment, Nexavar 400 mg will be orally administered twice daily every day until PD is shown.

Outcome(s)

• Primary Outcome: Progression-free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Patients who have had systemic treatment for renal cancer 2.Patients for whom the period after a surgery or the end of radiotherapy is less than 4 weeks at the start of protocol treatment 3.Patients suffering double carcinoma within 5 years. However, the following patients who received appropriate treatment are acceptable as the subjects. a. Basal cell carcinoma of the skin or squamous cell cancer b. Cervical cancer, stomach cancer, or colon cancer (in situ) 4.Patients diagnosed as brain metastasis, spinal cord compression, or meningitis carcinomatosa 5.Patients showing either of the following within 12 months before the start of protocol treatment: Myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral bypass graft, symptomatic congestive heart failure, cerebrovascular attack or transient ischemic attack, or pulmonary embolism 6.Patients with arrhythmia or atrial fibrillation (any grade) by CTCAE Ver. 3.0, or QTc interval prolongation at >450 msec in men and >470 msec in women 7.Patients with uncontrollable hypertension (>150/100 mmHg in spite of the most proper medication) 8.Patients administered warfarin continuously (oral administration of a low dose of warfarin up to 2 mg/day is acceptable) 9.Patients for whom human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases or hepatitis B or C virus are confirmed

Related Information

• Primary Sponsor: Osaka Urological Oncology Research Group
• Source(s) of Monetary Support: Osaka Kidney Foundation