Oral Mucositis MedDRA version: 16.1 Level: LLT Classification code 10028130 Term: Mucositis oral System Organ Class: 100000004856
Conditions
Interventions
Product Name: Palifermin (Kepivance)
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: palifermin
Current Sponsor code: palifermin
Concentration unit: mg milligram(s)
Concent
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease Related • Histologically confirmed diagnosis of colon adenocarcinoma • Newly diagnosed stage 2B or 3 (AJCC staging criteria; see Appendix F) resected colon carcinoma and a candidate for 5-FU/LV treatment Demographic • 18 years of age or older • ECOG performance status = 1 Baseline Laboratory • Hemoglobin (Hgb) = 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization • Absolute neutrophil count (ANC) = 1.5 x 109/L without growth factor use in the 2 weeks before study randomization • Platelet count = 100 x 109/L • Serum bilirubin = 1.5 x institutional upper limit of normal (ULN) • Serum creatinine = 2.0 mg/dL • Serum AST = 5 x ULN • Females of childbearing potential: negative serum or urine pregnancy test Ethical • Subject must give written informed consent before participating in any study-specific procedure General • Subjects with reproductive capability must agree to practice adequate contraception methods • Absence of other serious concurrent medical illness • Willingness to participate in subsequent long-term follow-up study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 51 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 49
Exclusion criteria
Exclusion criteria: Disease Related • Previous therapy (eg, 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 • Presence of active diarrhea > grade 1 according to CTCAE v. 3 grading criteria within three days prior to randomization • History of pancreatitis Medication/Prior Treatment • Four weeks or less since completion of treatment using an investigational product or device in another clinical study or presence of any unresolved toxicity from previous treatment • Known sensitivity to any of the products administered during dosing, including E. coli-derived products • Previous treatment on this study or with other keratinocyte growth factors Laboratory • Known to be sero-positive for human immunodeficiency virus (HIV) or Hepatitis C Virus (HCV) General • Subjects who would be unwilling/unable to complete daily patient-reported outcome questionnaires • Subjects of childbearing potential not using adequate contraceptive precautions • Pregnant or breast-feeding women • Psychological, social, familial, or geographical reasons that would prevent regular follow-up • Compromised ability of the subject to give written informed consent and/or to comply with study procedures • Refusal to sign an informed consent form to participate in this study or, if applicable, refusal to sign the hospital information release form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of palifermin on the incidence of Grade = 2 OM induced by adjuvant chemotherapy in subjects with stage 2B and 3 locally advanced colon cancer in cycle 1, when administered as a single dose of 120 µg/kg three days prior to each 4-week cycle of 5-FU and leucovorin;Secondary Objective: To assess the safety and tolerability of palifermin administered as a single dose of 120 µg/kg IV before each cycle of 5-FU and leucovorin To evaluate the effect of palifermin on patient-reported mouth and throat soreness To evaluate the incidence of Grade = 2 OM in cycle 2 To evaluate the duration of Grade = 2 OM To evaluate 5-FU dose reductions/delays To evaluate the long-term effects of palifermin on disease outcome and survival ;Primary end point(s): Incidence of grade = 2 (WHO scale) OM in cycle 1;Timepoint(s) of evaluation of this end point: 1 week (as per assessment at cycle 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary: • Incidence of grade = 2 (WHO scale) OM in cycle 2 • Average MTS score (OMDQ Question 2) in cycle 1 • Average MTS score (OMDQ Question 2) in cycle 2 • Incidence of 5-FU dose reductions and dose delays in cycle 2 • Duration of Grade = 2 (WHO scale) OM in cycle 1 • Duration of Grade = 2 (WHO scale) OM in cycle 2;Timepoint(s) of evaluation of this end point: week 1 and week 2 After completion of, or withdrawal from, the treatment phase, subjects will continue onto the long-term follow-up phase and will be monitored for disease progression, second primary tumors, other malignancies and overall survival until considered lost to follow-up, death, or for up to 5 years from the last subject randomized. | — |
Countries
Belgium, Czech Republic, Hungary, Poland
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed