Oral mucositis MedDRA version: 18.1 Level: LLT Classification code 10028130 Term: Mucositis oral System Organ Class: 100000004856
Conditions
Interventions
Product Name: Palifermin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Palifermin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6.25
Sponsors
Amgen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: • Histologically documented squamous cell carcinoma • Subjects with locally advanced, resected ( R0, R1) HNC ( American Joint Committee on Cancer [ AJCC] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx , • Radiation treatment field to receive planned dose of at least 50 Gy to areas of the oral cavity / oropharynx mucosa that can be visualized by non- instrumental oral inspection. Subjects with larynx or hypopharynx tumors are eligible only if the radiation oncologist anticipates at least 2 of the 9 anatomical areas in the oral cavity will receive a total dose of 50 Gy or more. • Signed informed consent • Subject is 18 years of age or older • ECOG performance status ( PS) = 2 Baseline laboratory assessments: - Hemoglobin ( Hgb) = 10g/ dL -White blood count ( WBC) > 3.5 x 109/ L or - Absolute neutrophil count ( ANC) > 1.5 x 109/ L - Platelet count = 100 x 109/ L - Serum bilirubin = 1.5 x institutional upper limits of normal ( ULN) - Serum creatinine = 2.0 mg/ dL; Subjects with a serum creatinine = 1.4 mg/ dL and = 2.0 mg/ dL need to demonstrate a 24- hr urinary creatinine clearance = 50 mL/min - Serum or urine pregnancy test: Negative 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 151 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: - Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors. - Metastatic disease (M1) / Stage IV C. - Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years). - History of chronic pancreatitis or an episode of acute pancreatitis within the last year - Prior radiotherapy to the site of disease. - Prior chemotherapy. - Other investigational procedures. - Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is for long-term follow-up/survival data. - Pregnant or breast-feeding women. - Refusal to use adequate contraceptive devices during treatment phase. - Known sensitivity to any of the products administered during dosing, including E coli-derived products. -Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). - Previous treatment on this study or with other keratinocyte growth factors. - Compromised ability of the subject to give written informed consent and/or to comply with study procedures. - Refusal to give written informed consent to participate in this study and to sign the hospital information release form. - Unwilling or unable to complete the patient-reported outcome questionnaires. - Psychological, social, familial, or geographical reasons that would prevent regular follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of palifermin administered at the dose of 120 mcg/kg IV in weekly doses (minimum of 7 weekly doses, until RT is complete) in reducing the incidence of severe [World Health Organization Grade 3 or 4] oral mucositis (OM) in locally advanced HNC subjects receiving RT with concurrent CT as adjuvant treatment for their disease (post-operative setting).;Secondary Objective: To assess the safety and tolerability of palifermin at the dose of 120 mg/kg IV weekly doses (minimum of 7 weekly doses, until RT is complete) in this patient population. To evaluate the effect of palifermin on the clinical sequelae of severe OM (eg, average patient-reported mouth and throat soreness [MTS] score), and on RT induced xerostomia in this patient population. To evaluate long-term effects of palifermin on disease outcome and survival in this patient population.;Primary end point(s): Primary Efficacy Endpoint: - Incidence (%) of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale). Secondary Efficacy Endpoints: - Duration of severe oral mucositis (WHO Grades 3 or 4). - Average daily patient-reported mouth and throat soreness score (as reported on the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer [OMWQ-HN]) - Time to onset of severe oral mucositis (WHO Grades 3 or 4) - Total dose of opioid analgesics used (mg of morphine equivalents) - Incidence of = 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT) - Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT) - Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher) Safety Endpoints: Short-term - Incidence of adverse events and laboratory abnormalities using the CTCAE v.3.0 toxicity scales. - Incidence of serum anti-palifermin antibody formation. - Disease progression at week 12. Safety Endpoints: Long-term - Time to disease progress | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: • Duration of severe oral mucositis (WHO Grades 3 or 4) • Average patient-reported mouth and throat soreness score (as reported on Question 3 of the Oral Mucositis Weekly Questionnaire for patients with Head and Neck Cancer [OMWQ-HN]) • Time to onset of severe oral mucositis (WHO Grades 3 or 4) • Total dose of opioid analgesics used (mg of morphine equivalents) • Incidence of unplanned breaks in RT =5 days (to include discontinuations of RT) • Incidence of unplanned breaks in CT =5 days (to include discontinuations of CT) • Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher);Timepoint(s) of evaluation of this end point: Oral mucosa evaluations will be performed: • At baseline • Twice weekly throughout RT/CT until resolution of OM to WHO Grade = 2 • Once weekly thereafter until resolution of OM to WHO Grade = 1 • If severe OM is not resolved by the week 12 visit, twice weekly assessments should be continued until week 15. If after the week 15 visit, OM is greater than or equal to WHO Grade 2, the OM evaluations should continue weekly until resolved to WHO Grade = 1. | — |
Countries
Australia, Austria, Canada, France, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed