Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 3: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 4: C140- Malignant neoplasm of pharynx, unspecified
Conditions
Interventions
Intervention1: etoposide, methotrexate, celecoxib: Methotrexate Tablet (15 mg/m2) PO on day 1 , day 8, day 15
Etoposide capsule 50 mg PO daily day 1 to day 14
Celecoxib Capsule 200 mg PO twice a day
Sponsors
Uttarakhand Manav Seva Samiti, Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with histologically or cytologically confirmed squamous cell carcinoma of the head and neck region 2. Locally advanced or metastatic tumor unsuitable for loco-regional therapy (involvement of skull base, prevertebral fascia, major vessels, gross mandibular erosion, oro-cutaneous fistula, or extensive disease which cannot be safely encompassed in radiation field). Palliative radiation for pain relief is acceptable. Patients who have taken prior lines of therapies are included provided they have a documented progression. 3. Age 18 years to 80 years. 4. Eastern Cooperative Oncology Group performance status 0, 1, 2. 5. Measurable disease as defined by response evaluation criteria in solid tumors (version 1.1) (7) 6. Adequate bone marrow function: Absolute Neutrophil Count (ANC) more than 1,500, platelets more than 100,000, hemoglobin more than 8 g) 7. Creatinine clearance using Cockroft Gault formula more than 45 ml/min 8. Adequate hepatic function: bilirubin less than 1.5 x UNL SGOT PT less than 30 or below the reference range of the lab 9. Adequate cardiac function as decided by clinical examination. 10. Women should use contraceptive medication for 6 months after the end of the study or she would be post-menopause status. Men should consent with the contraception for 6 months after the end of the study or he would be infertile. 11. Have financial constraints for immunotherapy or cetuximab based therapy 12. Patients should sign a written informed consent before study entry.
Exclusion criteria
Exclusion criteria: 1. Histologic types other than squamous cell or the primaries in the thyroid, salivary glands and nasopharynx should be excluded. 2.Decompensated, cardiac, pulmonary, renal, immunological disease, psychiatric illness, active tuberculosis and those seropositive for HIV, HBV and HCV not on treatment. 3. Those who have received methotrexate or etoposide in the prior lines of therapy or on celecoxib for any other reason. 4. Pregnant or lactating women, women of childbearing potential not employing adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the objective response rate (ORR) to oral etoposide, methotrexate and celecoxib combination in the locally advanced, inoperable, and metastatic head and neck cancer patients.Timepoint: response evaluation to be done after completion of 4 cycles 8 cycles 12 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate (CBR) of this regimen Progression free survival (PFS) of this regimen Toxicity associated with this regimen Timepoint: Last patient enrollment date 36 months from the date of IEC approval Data analysis 4 months Preparation of final report 2 months ;nilTimepoint: | — |
Countries
India
Contacts
Public ContactDeepak Sundriyal
All Indi Institute of Medical Sciences
Outcome results
None listed