Phase 2
N=15
Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer
Cancer of the Pharynx · Cancer of the Larynx · Cancer of the Neck · Paranasal Sinus Neoplasms · Cancer of the Head
Bottom Line
View on ClinicalTrials.gov: NCT00970502 ↗Enrolled (actual)
15
Serious AEs
100.0%
Results posted
Apr 2017
Primary outcome: Primary: Toxicity — 0; 1; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- erlotinib + celecoxib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnny Kao
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toxicity |
0; 1; 2 | — |
| SECONDARY Clinical Response |
6; 1; 5; 2 | — |
| SECONDARY Locoregional Progression |
4; 4; 2; 1; 3 | — |
| SECONDARY Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity |
60; 37; 55; 0 | — |
Summary
There is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surgery is not always possible and often cannot remove every cancerous cell. On the other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal complications. Therefore, less toxic and more effective reirradiation regimens are urgently needed. There are extensive data from animal studies and preliminary human studies showing that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans and appear to have less severe toxicity than conventional chemotherapeutic agents.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck or lymphoepithelioma
- Prior radiation to the head and neck, surgery or chemotherapy is allowed
- Karnofsky performance status of >= 70%
- Intact organ and bone marrow function
- Obtained informed consent
Exclusion Criteria
- Demonstration of metastatic disease (i.e. M1 disease).
- Incomplete healing from previous surgery
- Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician.
- Uncontrolled active infection unless curable with treatment of their cancer.
Data sourced from ClinicalTrials.gov (NCT00970502). 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.