EUCTR2004-002016-28-ES
Active, not recruiting
Phase 1
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy (RT/CT)
ConditionsOral mucositis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Oral mucositis
- Sponsor
- Amgen Ltd
- Enrollment
- 315
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically documented squamous cell carcinoma.
- •\- Subjects with newly diagnosed (locally advanced) resected (R0, R1\) HNC (American Joint Committee on Cancer \[AJCC] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx and suitable to receive adjuvant concurrent RT/CT.
- •\- Radiation treatment field to receive planned dose of at least 50 Gy to areas of the oral cavity / oropharynx mucosa that can be visualized by non\-instrumental oral inspection.
- •\- Subjects with larynx or hypopharynx tumors are eligible only if the radiation oncologist anticipates at least 2 of the 9 anatomical areas in the oral cavity \[Mucositis Assessments] will receive a total dose of 50 Gy or more.
- •\- Signed informed consent.
- •\- Subject is 18 years of age or older.
- •\- ECOG performance status (PS) less than or equal to 2\.
- •\- Planned interval \< 6 calendar days between randomization and the first dose of RT.
- •Baseline laboratory assessments:
- •\- Hemoglobin (Hgb) more than or equal to 10g/dL
Exclusion Criteria
- •\- Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors.
- •\- Metastatic disease (M1\) / Stage IV C.
- •\- Presence or history of any other primary malignancy.
- •\- History of pancreatitis.
- •\- Prior radiotherapy to the site of disease.
- •\- Prior chemotherapy.
- •\- Other investigational procedures.
- •\- Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is for long\-term follow\-up/survival data.
- •\- Pregnant or breast\-feeding women.
- •\- Refusal to use adequate contraceptive devices during treatment phase.
Outcomes
Primary Outcomes
Not specified
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