Health Condition 1: C140- Malignant neoplasm of pharynx, unspecified
Conditions
Interventions
Intervention1: Erlotinib, Celecoxib and Methotrexate.: Chemotherapy will be administered with tablet Erlotinib 150 mg (fixed-dose) PO OD daily, capsule Celecoxib 200 mg (fixed-dose) PO BD daily, and o
Sponsors
Cancer Research and Statistic Foundation CRSF
Eligibility
Inclusion criteria
Inclusion criteria: 1.Head and neck cancers planned for palliative chemotherapy and are either platinum-refractory (Platinum refractory would be defined as failure within 6 months of the last dose of platinum) or planned for the second line. 2.ECOG performance status 3.Participants must have normal organ and marrow function as per acceptable institutional standards for administering chemotherapy 4.Both men and women of all races and ethnic groups are eligible for this trial. 5.Willing and able to comply with all study requirements. 6.Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1.Uncontrolled intercurrent illness as per physician discretion 2.Pregnant women and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS)Timepoint: OS will be defined in time months between the date of randomization to date of death. Patients alive at their last follow-ups would be censored. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and Quality of Life (QoL)Timepoint: 1) Adverse events would be monitored during chemotherapy. 2) Quality of life (EORTC) would be collected at baseline, at 2 months and at 6 months. | — |
Countries
India
Contacts
Public ContactDr Ashay Karpe
Cancer Research and Statistic Foundation
Outcome results
None listed