UnknownPhase 2

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

India64 participantsStarted 2015-08-18

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Patients must be at least 18 years of age.
✓. All patients must sign an informed consent before enrolling in study.
✓. Patients must be able and willing to return to the clinic at appropriately scheduled intervals.
✓. 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).
✓. Premenopausal women must be using adequate birth control methods and have a negative pregnancy test prior to entry.
✓. Karnofsky Performance Score above 80.
✓. The subject is willing and able to fully participate for the duration of the study.

What they're measuring

Change in expression of selected biomarkers in tissue samples, assessed by immunohistochemistry (IHC) and PCR

Timeframe: baseline and 21 days

Trial details

NCT IDNCT02748707

SponsorTata Memorial Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2018-02-12

View on ClinicalTrials.gov More Oral Squamous Cell Carcinoma trials