Clinical trial · Interventional

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

A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy With Concurrent Chemotherapy

NCT00626639CI-TRIAL-00028204completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Mucositis	—	UNRESOLVED	—

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Cisplatin	Drug	Cisplatin	ALIAS
palifermin	Drug	—	UNRESOLVED
Placebo	Drug	—	UNRESOLVED
Radiotherapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
PLACEBO_COMPARATOR
label
Placebo
description
Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.
interventionNames
1. Drug: Placebo
2. Radiation: Radiotherapy
3. Drug: Cisplatin
type
EXPERIMENTAL
label
Palifermin
description
Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m\^2 on days 1, 22 and 43.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.