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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00101582
First received: January 12, 2005
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).


Condition Intervention Phase
Mucositis
Solid Tumors
Stomatitis
Head and Neck Cancer
Squamous Cell Carcinoma
Drug: Placebo
Drug: palifermin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Radiotherapy With Concurrent Chemotherapy (RT/CT)

Resource links provided by NLM:


Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:
  • Incidence of severe (WHO Grade 3 or 4) oral mucositis within 12 weeks after start of radiotherapy with concurrent chemotherapy [ Time Frame: within 12 weeks after start of radiotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-reported mouth and throat soreness within 4 months after treatment start [ Time Frame: within 4 months after treatment start ] [ Designated as safety issue: No ]
  • Duration of severe (WHO Grade 3 or 4) oral mucositis within 12 weeks after start of radiotherapy with concurrent chemotherapy [ Time Frame: within 12 weeks after start of radiotherapy ] [ Designated as safety issue: No ]
  • Unplanned breaks in radiotherapy or chemotherapy treatment within 8 weeks after treatment start [ Time Frame: within 8 weeks after treatment start ] [ Designated as safety issue: No ]
  • Total dose of opioid analgesics used for mucositis within 15 weeks [ Time Frame: within 15 weeks after treatment start ] [ Designated as safety issue: No ]
  • Disease progression, incidence of second malignancies, and survival (at least once yearly for life) [ Time Frame: for life ] [ Designated as safety issue: No ]

Enrollment: 188
Study Start Date: August 2005
Estimated Study Completion Date: February 2015
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: palifermin
Single IV dose of palifermin at 180 ug/kg 3 days before the start of RT, plus 7 once weekly placebo doses at the same dose level during a 7-week RT/CT course.
Drug: palifermin
Single IV dose of palifermin at 180 ug/kg 3 days before the start of RT, plus 7 once weekly placebo doses at the same dose level during a 7-week RT/CT course.
Placebo Comparator: placebo
Single IV dose of placebo at 180 ug/kg 3 days before the start of RT, plus 7 once weekly placebo doses at the same dose level during a 7-week RT/CT course.
Drug: Placebo
Single IV dose of placebo at 180 ug/kg 3 days before the start of RT, plus 7 once weekly placebo doses at the same dose level during a 7-week RT/CT course.
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
  • Newly diagnosed, locally advanced stage HNC (unresectable/unresected disease); American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable to RT/CT as the definitive treatment modality
  • At least 50 Gy of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized
  • Concurrent chemotherapy regimen of Cisplatin 100mg/m2 on days 1, 22, and 43
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2
  • Adequate hematologic, renal and hepatic function
  • Negative pregnancy test by serum or urine
  • Signed informed consent

Key Exclusion Criteria:

- 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 greater than 3 years)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101582

Sponsors and Collaborators
Swedish Orphan Biovitrum
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT00101582     History of Changes
Obsolete Identifiers: NCT00963456
Other Study ID Numbers: 20020402
Study First Received: January 12, 2005
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Swedish Orphan Biovitrum:
SCCHN
Palifermin
Mucositis
Oral Cavity
Oropharynx
Nasopharynx
Hypopharynx
Larynx
Mouth Pain
Mouth Sores
Radiation Therapy
Radiotherapy
Radiochemotherapy
Concurrent Chemotherapy
Xerostomia
Stomatitis
Mucosa
KGF
rHuKGF
Keratinocyte Growth Factor
HNC
Head and Neck Cancer
Oral Mucositis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Stomatitis
Mucositis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014