Effect of COX-2 and EGFR Suppression on Molecular Markers of Angiogenesis and Proliferation in Squamous Cell Carcinoma of Oral Cavity - Prospective Randomized Study

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II randomized clinical trial to 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tata Memorial Hospital
• Treatments: Celecoxib; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

1. All patients with squamous cell carcinoma of oral cavity (T2-T4, N1-2, M0) and are candidates for first line curative surgical treatment and are able to swallow orally, preoperatively.

2. Patients must be at least 18 years of age.

3. All patients must sign an informed consent before enrolling in study.

4. Patients must be able and willing to return to the clinic at appropriately scheduled intervals.

5. 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).

6. Premenopausal women must be using adequate birth control methods and have a negative pregnancy test prior to entry.

7. Karnofsky Performance Score above 80.

8. The subject is willing and able to fully participate for the duration of the study.

9. If applicable, the subject has been counseled on smoking cessation.

10. The subject meets the following laboratory eligibility criteria during a time not to exceed 4 weeks prior to randomization.

11. Hemoglobin level above 10gm/dl, the lower limit of normal.

12. WBC count > 3,000 mm3.

13. Platelets count > 100,000 m3.

14. Total bilirubin, AST (Aspartate Aminotransferase) and ALT (Alanine transaminase) ≤ 2 x ULN.

15. Serum creatinine ≤ 2 x Upper limit of Normal (ULN)

Exclusion Criteria:

1. 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. Neutrophil count of <1 x 109 per liter or platelet count of < 75 x 109 per liter at study entry, 6. Bilirubin at >1.5-fold above the upper limit of normal, and 7. Kidney failure (Glomerular filtration rate of <40 mL/min). 8. Pregnant women 9. Use other nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids within 2 weeks prior to initial clinical evaluation 10. The subject is, in the opinion of the Institutional Principal Investigator, not an appropriate candidate for study participation.

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