A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer
- Registration Number
- NCT00393822
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
This study is being conducted to determine whether administration of a single IV dose of palifermin 3 days before initiation of chemotherapy and 3 days before each subsequent treatment cycle would reduce the incidence of oral mucositis and to evaluate the safety profile in the subject population. This study will evaluate the efficacy of palifermin in reducing the incidence of grade ≥ 2 OM in subjects with stage 2B or stage 3 locally advanced, colon cancer undergoing adjuvant chemotherapy with 5-FU and leucovorin in cycle 1. This study will also assess the safety and tolerability of palifermin administered as a single IV dose before each cycle of 5-FU and leucovorin, evaluate the effect of palifermin on patient-reported mouth and throat soreness, the incidence of grade ≥ 2 oral mucositis in cycle 2, the duration of grade ≥ 2 oral mucositis, 5-FU dose reductions/delays and the long-term effects of palifermin on disease outcome and survival.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- History of newly diagnosed histologically confirmed resected colon cancer (American Joint Committee on Cancer [AJCC] Stage 2B or 3) and a candidate for adjuvant 5-FU and Leucovorin
- Eastern Cooperative Oncology Group performance status ≤ 1
- Functional hematopoietic and hepato-renal systems
- Previous therapy (e.g. chemotherapy, radiotherapy or biological therapy) for colon cancer, other than surgical tumor resection
- Presence or history of any other primary malignancy
- Presence of active or chronic oral mucositis or xerostomia
- Previous treatment with other keratinocyte growth factors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group placebo 50 subjects to receive matched placebo 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy. Palifermin palifermin 50 subjects to receive palifermin 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.
- Primary Outcome Measures
Name Time Method Incidence of Grade ≥ 2 (WHO scale) oral mucositis in Cycle 1 of chemotherapy treatment phase
- Secondary Outcome Measures
Name Time Method Incidence of chemotherapy (5-FU) dose reductions and dose delays in Cycle 2 of chemotherapy treatment phase Changes in laboratory values during Treatment Phase (6 cycles of chemotherapy) Duration of grade ≥ 2 (WHO scale) oral mucositis in Cycle 1 and in Cycle 2 of chemotherapy treatment phase Incidence and severity of adverse events during Treatment Phase (6 cycles of chemotherapy) Overall survival (OS) within long-term follow-up phase Incidence of grade ≥ 2 (WHO scale) oral mucositis in Cycle 2 of chemotherapy treatment phase Incidence of serum anti-palifermin antibody formation during Treatment Phase (6 cycles of chemotherapy) Progressive disease rate at 6 months Average mouth and throat soreness (MTS) score in Cycle 1 and in Cycle 2 of chemotherapy treatment phase Incidence of other malignancies within long-term follow-up phase Incidence of secondary primary tumors within long-term follow-up phase Progression-free survival (PFS) within long-term follow-up phase