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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of treatment-emergent proteinuria

Outcome Time Frame:

11 weeks

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Biovitrum AB (publ)

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

20070201

NCT ID:

NCT00540332

Start Date:

October 2007

Completion Date:

September 2008

Related Keywords:

  • Head and Neck Cancer
  • Oncology
  • KGF
  • HNC
  • head and neck
  • oral mucositis
  • OM
  • proteinurea
  • palifermin
  • clinical trial
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis

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