Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell carcinoma of the skin.
Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Given orally
Stanford University Hospitals and Clinics
Stanford, California, United States
Objective Response Rate (ORR)
Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: 9 weeks (3 cycles)
Progression-free Survival (PFS) at 1 Year
Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.
Time frame: 1 year
Progression-free Survival (PFS) at 2 Years
Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.
Time frame: 2 years
Overall Survival (OS) at 1 Year
Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.
Time frame: 1 year
Overall Survival (OS) at 2 Years
Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.
Time frame: 2 years
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