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

This study has been withdrawn prior to enrollment.
(The 20070201 study was terminated based on evaluation of Palifermin solid tumor data.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540332
First Posted: October 8, 2007
Last Update Posted: March 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by:
Swedish Orphan Biovitrum
  Purpose
The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.

Condition Intervention Phase
Head and Neck Cancer Drug: Placebo Drug: palifermin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy

Resource links provided by NLM:


Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:
  • Incidence of treatment-emergent proteinuria [ Time Frame: 11 weeks ]
  • Duration of treatment-emergent proteinuria [ Time Frame: 11 weeks ]
  • Incidence of chronic proteinuria [ Time Frame: 11 weeks ]
  • Time (days) to onset of treatment-emergent proteinuria [ Time Frame: 11 weeks ]
  • Maximum protein-to-creatinine ratio values during the treatment period [ Time Frame: 11 weeks ]
  • Pharmacokinetic profile to include Systemic clearance, volume of distribution at steady state, estimated initial concentration, area under the conc-time curve, terminal half-life and mean residual time [ Time Frame: in Week 1 ]

Secondary Outcome Measures:
  • Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4 [ Time Frame: 11 weeks ]
  • Disease status at End of Treatment visit [ Time Frame: 11 weeks ]
  • Incidence of serum anti-palifermin antibody formation [ Time Frame: 11 weeks ]
  • Incidence of second primary tumors [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ]
  • Incidence of other malignancies [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ]
  • Progression-free survival [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ]
  • Overall survival [ Time Frame: up to 10 years (Long-Term Follow-Up phase) ]
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: 11 weeks ]
  • Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4 [ Time Frame: 11 weeks ]

Enrollment: 0
Study Start Date: October 2007
Estimated Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo

Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows:

  • PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects
  • Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.
Drug: Placebo
Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.
Experimental: Palifermin

Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows:

  • PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects
  • Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects.
Drug: palifermin
120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1)
  • Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg

Exclusion Criteria:

  • Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins
  • Metastatic disease (M1)
  • Presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years
  • History of pancreatitis
  • Prior radiotherapy to the site of disease
  • Prior chemotherapy or requiring chemotherapy during treatment phase of study
  • Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540332


Sponsors and Collaborators
Swedish Orphan Biovitrum
Amgen
Investigators
Study Director: MD Biovitrum AB (publ)
  More Information

Additional Information:
Responsible Party: Clinical Development, Biovitrum AB (publ)
ClinicalTrials.gov Identifier: NCT00540332     History of Changes
Obsolete Identifiers: NCT00965159
Other Study ID Numbers: 20070201
First Submitted: October 4, 2007
First Posted: October 8, 2007
Last Update Posted: March 2, 2009
Last Verified: January 2009

Keywords provided by Swedish Orphan Biovitrum:
Oncology
KGF
HNC
head and neck
oral mucositis
OM
proteinurea
palifermin
clinical trial

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases