A Phase 2/3 interventional study of palifermin and placebo in Colon Cancer, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-15.
Sponsored by Amgen · Phase 2/3, Interventional, and Supportive care
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.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 100 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 subjects to receive palifermin 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.
Drug: palifermin
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
dose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles
Also known as: KGF
one bolus IV injection at 120 μg/kg/day of matched placebo
Also known as: Pbo
Incidence of Grade ≥ 2 (WHO scale) oral mucositis
Time frame: in Cycle 1 of chemotherapy treatment phase
Incidence of chemotherapy (5-FU) dose reductions and dose delays
Time frame: in Cycle 2 of chemotherapy treatment phase
Average mouth and throat soreness (MTS) score
Time frame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
Duration of grade ≥ 2 (WHO scale) oral mucositis
Time frame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
Incidence and severity of adverse events
Time frame: during Treatment Phase (6 cycles of chemotherapy)
Changes in laboratory values
Time frame: during Treatment Phase (6 cycles of chemotherapy)
Incidence of serum anti-palifermin antibody formation
Time frame: during Treatment Phase (6 cycles of chemotherapy)
Progressive disease rate
Time frame: at 6 months
Incidence of secondary primary tumors
Time frame: within long-term follow-up phase
Incidence of other malignancies
Time frame: within long-term follow-up phase
Progression-free survival (PFS)
Time frame: within long-term follow-up phase
Overall survival (OS)
Time frame: within long-term follow-up phase
Incidence of grade ≥ 2 (WHO scale) oral mucositis
Time frame: in Cycle 2 of chemotherapy treatment phase
No study locations are listed for this record.
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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