Phase 2
N=5
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
Mucositis · Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00626639 ↗Enrolled (actual)
5
Serious AEs
40.0%
Results posted
Mar 2014
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 2; 3; 0; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); palifermin (Drug); Radiotherapy (Radiation); Cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Swedish Orphan Biovitrum
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
2; 3; 0; 2; 0; 2 | — |
| PRIMARY Ratio of Ki67-positive Cells Before and After Palifermin Treatment |
— | — |
| PRIMARY Pharmacokinetics of Palifermin |
— | — |
| SECONDARY Number of Participants With Severe Oral Mucositis (OM) (Adapted RTOG/EORTC Grade ≥3) |
— | — |
| SECONDARY Patient-Reported Mouth and Throat Soreness Score |
— | — |
| SECONDARY Number of Participants With Disease Progression by Week 12 |
1; 0 | — |
| SECONDARY Overall Survival |
2; 2 | — |
Summary
Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting
Eligibility Criteria
Inclusion Criteria
- History of newly diagnosed histologically confirmed squamous cell carcinoma (American Joint Committee on Cancer [AJCC] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx, post surgical resection (R0, R1)
- Scheduled to receive adjuvant concurrent chemoradiation treatment within 12 weeks of surgery
- High-risk subject defined by presence of at least one of the following: R1 resection margins; T3 or T4 tumor stage; 3 or more positive lymph node metastases; <3 lymph node metastases with extracapsular extension of the disease
- Radiation treatment field to receive planned dose of at least 50Gy to areas of the oral cavity/oropharynx mucosa that can be visualized
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
Data sourced from ClinicalTrials.gov (NCT00626639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.