drugset / Trial / NCT02218164

Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma

NCT02218164

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in patients with squamous cell carcinoma of the skin. Specifically, investigators want to determine if the combination of 5-FU/Capecitabine (oral pills) and Interferon alpha-2b (injection) can help people with advanced cases of squamous cell carcinoma of the skin. For participants that are not approved for oral capecitabine, treating physicians will use continuous infusion 5-FU. Both 5-FU/Capecitabine and Interferon alpha-2b have been used separately to treat squamous cell carcinoma of the skin and are FDA approved in other cancer types.

Timeline

Start
2014-08-12
Primary completion
2017-07-19
Completion
2018-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 800 mg/m2 Oral
Subject Peginterferon alfa-2b Protein / enzyme biologic 3 ug/kg Subcutaneous
Subject fluorouracil Small molecule 800 mg/m2 Other