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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00131638
First received: July 26, 2005
Last updated: October 23, 2013
Last verified: October 2013

July 26, 2005
October 23, 2013
January 2005
November 2007   (final data collection date for primary outcome measure)
Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00131638 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Time to onset of severe oral mucositis (WHO Grades 3 or 4) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Total dose of opioid analgesics used (mg of morphine equivalents) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Duration of severe oral mucositis (WHO Grades 3 or 4) [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Head and Neck Cancer
  • 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 Name: Pbo
  • 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 Name: KGF
  • 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
    Intervention: Drug: Palifermin
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
241
June 2017
November 2007   (final data collection date for primary outcome measure)

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-
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00131638
20040118
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP