NCT00131638

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P50-P75 for phase_3 head-and-neck-cancer

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3 head-and-neck-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

2.8 years

First QC Date

July 26, 2005

Last Update Submit

December 14, 2016

Conditions

Head and Neck Cancer

Keywords

OncologyKGFPaliferminOral mucositisClinical TrialAmgenhead and neck

Outcome Measures

Primary Outcomes (1)

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

    Up to 24 weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Palifermin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

PlaceboDRUG

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.

Also known as: Pbo
Placebo
PaliferminDRUG

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

Also known as: KGF
Palifermin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Henke M, Alfonsi M, Foa P, Giralt J, Bardet E, Cerezo L, Salzwimmer M, Lizambri R, Emmerson L, Chen MG, Berger D. Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial. J Clin Oncol. 2011 Jul 10;29(20):2815-20. doi: 10.1200/JCO.2010.32.4103. Epub 2011 Jun 13.

    PMID: 21670447BACKGROUND

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasmsStomatitis

Interventions

Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

Neoplasms by SiteMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fibroblast Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2005

First Posted

August 19, 2005

Study Start

January 1, 2005

Primary Completion

November 1, 2007

Study Completion

July 1, 2016

Last Updated

December 16, 2016

Record last verified: 2016-12