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:

Amgen

ClinicalTrials.gov Identifier:

NCT00131638

First received: July 26, 2005

Last updated: January 20, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 26, 2005

Last Updated Date

January 20, 2011

Start Date ^ICMJE

January 2005

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00131638 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

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.
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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

241

Estimated Completion Date

June 2017

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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-

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00131638

Other Study ID Numbers ^ICMJE

20040118

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

January 2011

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

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