A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) for Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer Receiving 5-FU and Leucovorin as Adjuvant Therapy

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: palifermin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palifermin<br>50 subjects to receive palifermin 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy. | Drug: palifermin<br>* dose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles<br>* Other names: KGF;|
| Placebo Comparator: Control Group<br>50 subjects to receive matched placebo 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy. | Drug: placebo<br>* one bolus IV injection at 120 μg/kg/day of matched placebo<br>* Other names: Pbo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Grade ≥ 2 (WHO scale) oral mucositis |  | in Cycle 1 of chemotherapy treatment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chemotherapy (5-FU) dose reductions and dose delays |  | in Cycle 2 of chemotherapy treatment phase | 
| Average mouth and throat soreness (MTS) score |  | in Cycle 1 and in Cycle 2 of chemotherapy treatment phase | 
| 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) | 
| Changes in laboratory values |  | during Treatment Phase (6 cycles of chemotherapy) | 
| Incidence of serum anti-palifermin antibody formation |  | during Treatment Phase (6 cycles of chemotherapy) | 
| Progressive disease rate |  | at 6 months | 
| Incidence of secondary primary tumors |  | within long-term follow-up phase | 
| Incidence of other malignancies |  | within long-term follow-up phase | 
| Progression-free survival (PFS) |  | within long-term follow-up phase | 
| Overall survival (OS) |  | within long-term follow-up phase | 
| Incidence of grade ≥ 2 (WHO scale) oral mucositis |  | in Cycle 2 of chemotherapy treatment phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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KGF, Palifermin, Oral Mucositis, Clinical Trial, Amgen, Oncology, Colon Cancer