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

NCT ID: NCT00131638

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Keywords

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Oncology KGF Palifermin Oral mucositis Clinical Trial Amgen head and neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Palifermin

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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 Type 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

Intervention Type DRUG

Other Intervention Names

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Pbo KGF

Eligibility Criteria

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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-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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Australia Austria Canada France Germany Italy Spain United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 21670447 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_24_KGF_20040118.pdf

To access clinical trial results information click on this link

http://www.kepivance.com/

FDA-approved Drug Labeling

Other Identifiers

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20040118

Identifier Type: -

Identifier Source: org_study_id