Effect of Celecoxib and Erlotinib in Oral Cancers

Phase 2

Conditions: Health Condition 1: null- Oral cancer

Registration Number: CTRI/2012/07/002828

Lead Sponsor: Tata Memorial Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br> <br/ ><br>Marker analysis after recruitment of all (64) patients. <br/ ><br> <br/ ><br>Followup for 36 months. <br/ ><br> <br/ ><br>Survival analysis after 36 months.

Secondary Outcome Measures

Name	Time	Method
•To evaluate the effect of Celecoxib and Erlotinib on tumor perfusion and growth as assessed by perfusion MR scans before and after treatment. <br/ ><br>•To study the base line expression of EGFR and COX-2 in OSCC and changes in their expression levels after the targeted therapy <br/ ><br>Timepoint: After 21 days before surgery <br/ ><br> <br/ ><br>2. along with the marker analysis <br/ ><br>