Health Condition 1: C729- Malignant neoplasm of central nervous system, unspecified Health Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Erlotinib, Celecoxib,
Methotrexate and Docetaxel: 1) Metronomic Chemotherapy Schedule:
Erlotinib 150 mg (fixed-dose)
PO OD daily, capsule Celecoxib 200 mg (fixed-dose) PO BD
daily, and
Sponsors
Cancer Research and Statistics Foundatiion
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 or beyond. 2. ECOG performance status of more than or equal to 2 3. Participants must have normal organ and marrow function as per acceptable institutional standards for administering chemotherapy. 4. Patients would have either exhausted the option of checkpoint inhibitors or it will not be accessible to them. 5. Both men and women of all races and ethnic groups are eligible for this trial. 6. Willing and able to comply with all study requirements. 7. Ability to understand 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) will be the primary outcome of the study.Timepoint: OS will be assessed as time in months from the date of randomization to the date of death. Patients alive at their last follow-ups will also be censored. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events will be the secondary outcome of the study.Timepoint: Adverse events will be assessed during the entire chemotherapy duration of the study. | — |
Countries
India
Contacts
Public ContactDr Ashay Karpe
Cancer Research and Statistics Foundation
Outcome results
None listed