Phase II Randomized Study of Docetaxel With or Without Low-dose, Short Course Sunitinib in the Treatment of Advanced Solid Tumors
This is a single-centre, phase II randomized study. Eligible patients will be randomized to
docetaxel with or without intermittent sunitinib. A total of eighty patients with measurable
tumor will be enrolled over a period of 24-36 months. Eligible patients will be randomized
1:1 to either arm A or arm B. Patients will be stratified according to site of primary tumor
(breast vs non-small cell lung cancer vs others) for randomization purposes.
Arm A (Control arm):
Docetaxel 75mg/m2 day 1, every 3 weeks
Arm B (Experimental arm):
Docetaxel 75mg/m2 day 1, every 3 weeks, preceded by 7 days of sunitinib 12.5mg orally daily
during each cycle.
Patients will be treated for a maximum of 6 cycles of chemotherapy in the absence of tumor
progression or unacceptable toxicities.
Patient will be evaluated weekly for toxicity assessments and full blood count during cycle
1, and on days 1 and 15 of each subsequent cycle.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Soo Chin Lee, MBBS
National University Hospital, Singapore
Singapore: Domain Specific Review Boards