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A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy

NCT00626639 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-06-21

Study results available
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Summary

Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting

Conditions

Interventions

DRUG

Placebo

Administered by intravenous (IV) bolus injection

DRUG

palifermin

Administered by intravenous (IV) bolus injection

RADIATION

Radiotherapy

Once daily irradiation of 20 centigray (cGy)/day x 33 fractions for a total target dose of 6600 cGy (conventional radiation therapy using standard fractionation \[one fraction per day\])

DRUG

Cisplatin

100 mg/m\^2 intravenously (IV) on days 1, 22 and 43.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-05-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00626639 on ClinicalTrials.gov