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NCT Number: NCT00131638

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

Placebo

Drug

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

Palifermin

Drug

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

Primary outcomes

  1. Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)

    Time frame: Up to 24 weeks

Secondary outcomes

  1. 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 frame: 16 weeks

  2. Time to onset of severe oral mucositis (WHO Grades 3 or 4)

    Time frame: 12 weeks

  3. Total dose of opioid analgesics used (mg of morphine equivalents)

    Time frame: 16 weeks

  4. Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT)

    Time frame: 12 weeks

  5. Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)

    Time frame: 10 years

  6. Duration of severe oral mucositis (WHO Grades 3 or 4)

    Time frame: 15 weeks

  7. Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2007
Study completion
2016
First posted
Aug 19, 2005
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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