Colon Cancer
Conditions
Keywords
KGF, Palifermin, Oral Mucositis, Clinical Trial, Amgen, Oncology, Colon Cancer
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.
Interventions
DRUGpalifermin
dose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles
DRUGplacebo
one bolus IV injection at 120 μg/kg/day of matched placebo
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade ≥ 2 (WHO scale) oral mucositis | in Cycle 1 of chemotherapy treatment phase |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Incidence of chemotherapy (5-FU) dose reductions and dose delays | in Cycle 2 of chemotherapy treatment phase |
| 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 |
| Progressive disease rate | at 6 months |
Outcome results
None listed