Health Condition 1: C10- Malignant neoplasm of oropharynx Health Condition 2: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: erlotinib, methotrexate, celecoxib: The treatment regimen will consist of the following drugs:
1. Erlotinib (150 mg daily)
2. Methotrexate (9 mg/m weekly)
3. Celecoxib (200 mg twice da
Sponsors
Dr Vivek Tiwari
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed Stage IV inoperable oral cavity and oropharyngeal cancers. 2. Age more than 18 Years 3. ECOG performance status less than or equal to 2 4. No prior treatment received 5. Adequate organ function (liver, kidney, bone marrow) as determined by laboratory tests 6. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Age less than 18 Years 2. Active infection or significant comorbidities 3. Previous history of severe allergic reactions to any of the study drugs 4. Pregnancy or breastfeeding 5. Previous history of any treatment for present malignancy 6. Other malignancies within the past 5 years, except for basal cell carcinoma or in situ cervical cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment safety using CTCAE criteria, treatment tolerability in terms of patient related outcomes, patient adherenceTimepoint: Evaluation will be done at each chemotherapy cycle of 21 days and after 7 days of treatment completion, which is on the 49th day from the 1st chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Vivek Tiwari
Outcome results
None listed