Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin

Phase 2

Terminated

• Conditions: Squamous Cell Carcinoma of the Skin; Recurrent Skin Cancer
• Interventions: Drug: Capecitabine

• Registration Number: NCT01823679
• Lead Sponsor: Stanford University

Brief Summary

Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell carcinoma of the skin.

Detailed Description

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-29
• Study First Submitted QC: 2013-03-29
• Study First Posted: 2013-04-04
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2017-01-20
• Results First Submitted QC: 2017-01-20
• Results First Posted: 2017-03-10
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine 1000 mg/m²	Capecitabine	Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m² doses on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	9 weeks (3 cycles)	Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) at 1 Year	1 year	Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.
Progression-free Survival (PFS) at 1 Year	1 year	Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.
Progression-free Survival (PFS) at 2 Years	2 years	Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.
Overall Survival (OS) at 2 Years	2 years	Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.

Trial Locations

Locations (1)

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States