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1 Clinical Trial Details (PDF Generation Date :- Thu, 22 Nov :49:28 GMT) CTRI Number Last Modified On 25/04/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/07/ [Registered on: 25/07/2012] - Trial Registered Prospectively No Interventional Drug Biological Randomized, Parallel Group, Multiple Arm Trial Effect of Celecoxib and Erlotinib in Oral Cancers Effect Of COX-2 and EGFR Suppression On Molecular Markers Of Angiogenesis And Proliferation In Squamous Cell Carcinoma Of Oral Cavity A Prospective Randomized Study. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CT-Drugs/206/2011 TMC IRB project no 830 DCGI Other Details of Principal Investigator Kharghar Mumbai Head and Neck Details Contact Person (Scientific Query) Kharghar Mumbai Head and Neck Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent > Tata Memorial Centre Type of Sponsor NIL List of Countries of Principal Investigator Kharghar Mumbai Head and Neck Source of Monetary or Material Support Primary Sponsor Details Tata Memorial Centre Tata Memorial Centre, Tata Memorial Hospital, Parel, Mumbai Research institution and hospital NIL of Site Site Phone/Fax/ Head and Neck unit Advanced Centre for Treatment, Research & Education in Cancer (ACTREC),Tata Memorial Centre (TMC), Kharghar- Mumbai of Committee Approval Status Date of Approval Is Independent Ethics Committee? Tata Memorial Hospital IRB/ Ethics committee Status Approved 16/05/2012 No Date Approved/Obtained 09/12/2011 Health Type Patients Condition Oral cancer Type Details Intervention Celecoxib Arm 1: Celecoxib 200mg twice daily. Surgery after 21 days. Intervention Erlotinib Erlotinib 150mg daily for 21 page 2 / 5

3 Inclusion Criteria Intervention Celecoxib 200mg + Erlotinib 150mg days arm 2 Celecoxib 200 mg twice daily + Erlotinib 150 mg once daily for 21 days. Surgery after completion of 21 days treatment. Comparator Agent No drugs Patients will be operated 21 days after recruitment Age From Age To Gender Details Year(s) Year(s) Both 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 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 Details 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 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Open Label Primary Outcome Outcome Timepoints o To study the effect of COX-2 inhibitor Celecoxib and EGFR tyrosine kinase inhibitor Clinical response assessment after 21days of drug treatment. page 3 / 5

4 Erlotinib alone or in combination on molecular markers of apoptosis and angiogenesis. Markers to be studied include VEGF and p53. Marker analysis after recruitment of all (64) patients. Followup for 36 months. Survival analysis after 36 months. Secondary Outcome Outcome Timepoints 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 After 21 days before surgery 2. along with the marker analysis Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Total Sample Size=64 Sample Size from =64 01/08/2012 No Date Specified Years=3 Months=0 Days=0 Not Applicable Open to Recruitment NA Brief Summary Introduction : This is 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. Markers to to be studied include VEGF and p53. We propose a prospective phase II randomized trial based on a 2 X 2 factorial design in which patients are randomized to COX-2 inhibition vs. no COX-2 inhibition. Each arm will be further randomized to Erlotinib vs. no Erlotinib. This results in the following treatment combinations. Arm 1: Celecoxib 200mg twice daily page 4 / 5

5 Powered by TCPDF ( PDF of Trial Arm 2: Celecoxib 200mg twice daily + Erlotinib 150mg daily Arm 3: Erlotinib 150mg alone Arm 4: Control group with no drug Patients in the drug treatment arm will receive the prescribed drug for 21 days. All patients will undergo surgical resection at the end of the 3 rd week. page 5 / 5