A Study of Palifermin for the Reduction of Oral Mucositis in Subjects with Stage 2B or 3 Locally Advanced, Colon Cancer
Study Details
The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral mucositis in subjects with stage 2B and 3 locally advanced, colon cancer receiving chemotherapy as an adjuvant treatment for their disease.
Protocol Summary
Incidence of Grade ≥ 2 (WHO scale) oral mucositis
Timeframe: in Cycle 1 of chemotherapy treatment phase
Incidence of chemotherapy (5-FU) dose reductions and dose delays
Timeframe: in Cycle 2 of chemotherapy treatment phase
Average mouth and throat soreness (MTS) score
Timeframe: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
Duration of grade ≥ 2 (WHO scale) oral mucositis
Timeframe: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
Incidence and severity of adverse events
Timeframe: during Treatment Phase (6 cycles of chemotherapy)
Changes in laboratory values
Timeframe: during Treatment Phase (6 cycles of chemotherapy)
Incidence of serum anti-palifermin antibody formation
Timeframe: during Treatment Phase (6 cycles of chemotherapy)
Progressive disease rate
Timeframe: at 6 months
Incidence of secondary primary tumors
Timeframe: within long-term follow-up phase
Incidence of other malignancies
Timeframe: within long-term follow-up phase
Progression-free survival (PFS)
Timeframe: within long-term follow-up phase
Overall survival (OS)
Timeframe: within long-term follow-up phase
Incidence of grade ≥ 2 (WHO scale) oral mucositis
Timeframe: in Cycle 2 of chemotherapy treatment phase