Health Condition 1: null- Oral cancer
Conditions
Interventions
Intervention1: 1. Arm :Celecoxib
2. Arm 2:Erlotinib
3. Arm 3:Celecoxib and Erlotinib
: 1. Arm 1: Celecoxib 200mg twice daily
2. Arm 2:Erlotinib 150mg alone
3. Arm 3:Celcoxib 200mg twice daily+Erlot
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Patients must be at least 18 years of age. 2. All patients must sign an informed consent before enrolling in study. 3. Patients must be able and willing to return to the clinic at appropriately scheduled intervals. 4. No use of systemic steroids or topical oral steroid preparations within three months. (Topical nasal steroid sprays or cutaneous preparations with minimal systemic absorption for nasal or dermatologic disorders are allowed). 5. Karnofsky Performance Score above 80. 6. The subject is willing and able to fully participate for the duration of thestudy. 7. If applicable, the subject has been counseled on smoking cessation. 8. The subject meets the following laboratory eligibility criteria during a time not to exceed 4 weeks prior to randomization. ? Hemoglobin level above 10gm/dl, the lower limit of normal. ? WBC count > 3,000 mm3. ? Platelets count > 100,000 m3. ? Total bilirubin, AST (SGOT) and ALT (SGPT) 2 x ULN. Serum creatinine_ 2 x ULN.
Exclusion criteria
Exclusion criteria: History of cardiovascular co morbidities. 2. Patients with previous history of head and neck cancers. 3. Recent massive gastrointestinal hemorrhage. 4. An on-going unmanaged serious infectious disease or major metabolic disorder. 5. Bilirubin at 1.5-fold above the upper limit of normal, and Kidney failure (Glomerular filtration rate of 40 mL/min). 6. Pregnant women. 7. Use other non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids within 2 weeks prior to initial clinical evaluation. 8. The subject is, in the op inion of the Institutional Principal Investigator, not an appropriate candidate for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oTo study the effect of COX-2 inhibitor Celecoxib and EGFR tyrosine kinase inhibitor Erlotinib alone or in combination on molecular markers of apoptosis and angiogenesis. Markers to be studied include VEGF and p53.Timepoint: Clinical response assessment after 21days of drug treatment. Marker analysis after recruitment of all (64) patients. Followup for 36 months. Survival analysis after 36 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate the effect of Celecoxib and Erlotinib on tumor perfusion and growth as assessed by perfusion MR scans before and after treatment. • To study the base line expression of EGFR and COX-2 in OSCC and changes in their expression levels after the targeted therapy Timepoint: After 21 days before surgery 2. along with the marker analysis | — |
Countries
India
Contacts
Public ContactDr Sudhir V Nair
Tata memorial Centre- ACTREC
Outcome results
None listed