A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00131638

Collaborator

(none)

241

Enrollment

Arms

138

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent chemotherapy as adjuvant treatment for their disease.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: Placebo Drug: Palifermin	Phase 3

Detailed Description

This study is being conducted to evaluate the efficacy of palifermin administered intravenously (IV) in weekly doses (minimum of 7 weekly doses, until RT was complete) in reducing the incidence of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis in subjects with locally advanced HNC receiving RT concurrent with CT (RT/CT) as adjuvant treatment for their disease (postoperative setting). This study will assess the safety and tolerability of palifermin at the dose of 120 μg/kg IV administered weekly (minimum 7 weekly doses, until RT was complete) in this subject population. This study will also evaluate the effect of palifermin on the clinical sequelae of severe OM (eg, average subject-reported mouth and throat soreness [MTS] score), and on RT-induced xerostomia in this population, as well as the long-term effects of palifermin on disease outcome and survival in this population.

Study Design

Study Type:

Interventional

Actual Enrollment :

241 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy(RT/CT)

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Palifermin Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course	Drug: Palifermin Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course Other Names: KGF
Placebo Comparator: Placebo Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.	Drug: Placebo Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course. Other Names: Pbo

Arm

Intervention/Treatment

Experimental: Palifermin

Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course

Drug: Palifermin

Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course

Other Names:

KGF

Placebo Comparator: Placebo

Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.

Drug: Placebo

Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.

Other Names:

Pbo

Outcome Measures

Primary Outcome Measures

Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale) [Up to 24 weeks]

Secondary Outcome Measures

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] [16 weeks]
Time to onset of severe oral mucositis (WHO Grades 3 or 4) [12 weeks]
Total dose of opioid analgesics used (mg of morphine equivalents) [16 weeks]
Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT) [12 weeks]
Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher) [10 years]
Duration of severe oral mucositis (WHO Grades 3 or 4) [15 weeks]
Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT) [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

History of histologically documented squamous cell carcinoma ( AJCC [American Joint Committee on Cancer] Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (R0, R1) and candidates for adjuvant RT/CT
Radiation treatment field to receive planned dose of at least 50Gy to area of the oral cavity/oropharynx mucosa that can be visualized
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Functional hematopoietic and hepato-renal systems

Exclusion Criteria:

Tumors of the lips, paranasal sinuses, salivary glands, or 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)
History of chronic pancreatitis or episode of acute pancreatitis within the last year
Prior radiation to the site of the disease, or prior chemotherapy-