Health Condition 1: C412- Malignant neoplasm of vertebral column
Conditions
Interventions
Intervention1: Erlotinib plus Everolimus: Single arm Phase II study. Erlotinib 150 mg orally once daily continuous dosing taken fasting. Everolimus 2.5 mg orally every alternate day continuous dosing.
Sponsors
Dr BRA Institute Rotary Cancer Hospital IRCH All India Institute of Medical Sciences AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: Participants must have histologically confirmed locally advanced, unresectable, or metastatic chordoma. Patients should have either radiologically progressive disease within the previous six months according to RECIST version 1.1 or clinically or radiologically documented symptomatic disease. Eligible participants must be adults aged eighteen years or older. Eastern Cooperative Oncology Group performance status should be two or less, although patients with performance status three or four may be included if the limitation is solely due to disease related disability. Patients must have measurable or evaluable disease as defined by RECIST version 1.1 or CHOI criteria. Adequate organ function is required, including hemoglobin of at least eight grams per deciliter, absolute neutrophil count of one thousand per microliter or higher, and platelet count of one hundred thousand per microliter or higher. Liver function must meet protocol limits with serum bilirubin not exceeding one point five times the upper limit of normal, aspartate aminotransferase and alanine aminotransferase not exceeding three times the upper limit of normal or five times if liver metastases are present, and alkaline phosphatase not exceeding three times the upper limit of normal or five times if bone or liver metastases are present. Renal function must be adequate with serum creatinine two milligrams per deciliter or less or estimated glomerular filtration rate at least forty five milliliters per minute. Participants must be able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Concurrent uncontrolled medical conditions that could compromise protocol adherence or interfere with drug administration (e.g., severe cardiac, hepatic, or pulmonary disease). 2. Active uncontrolled infection. 3. Pregnant or breastfeeding women. 4. Known hypersensitivity to erlotinib or any component of its formulation. 5. Psychiatric or social conditions likely to interfere with study compliance, follow-up, or informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the 6-month progression-free survival (PFS) rate in patients with symptomatic or progressive, advanced, or metastatic chordoma treated with Erlotinib + Everolimus, using RECIST v1.1 criteria. Progressive disease: progression within the last 6 months as per RECIST v1.1.Timepoint: To assess the 6-month progression-free survival (PFS) rate in patients with symptomatic or progressive, advanced, or metastatic chordoma treated with Erlotinib + Everolimus, using RECIST v1.1 criteria. Progressive disease: progression within the last 6 months as per RECIST v1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the 6-months PFS rate using CHOI criteria.Timepoint: 6 months;2. To determine the 9 months and 12 months PFS rate using RECIST v1.1 and CHOI criteria.Timepoint: 9 months and 12 months;3. To determine the objective response rate (ORR), disease control rate (DCR) at 6 months, 9 months and 12 months using RECIST v1.1 and CHOI criteria.Timepoint: 9 months and 12 months;4. To estimate overall survival (OS) at 6 months, 9 months and 12 months using RECIST v1.1 and CHOI criteria.Timepoint: 6 months, 9 months and 12 months;5. To compare PFS, OS, and DCR outcomes between patients with and without EGFR amplification, using RECIST v1.1 and CHOI criteria.Timepoint: -;6. To evaluate the safety and tolerability profile of the combination, with adverse events graded according to NCI CTCAE version 5.0.Timepoint: -;7. To assess longitudinal changes in health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire at 0, 3, 6 and 12 months.Timepoint: 0, 3, 6 and 12 months;8. To assess pain control and symptom burden using the Edmonton Symptom Assessment System-revised (ESAS-r) at 0, 3, 6 and 12 months.Timepoint: 0, 3, 6 and 12 months. | — |
Countries
India
Contacts
Public ContactDr Sameer Rastogi
Dr. BRA IRCH, All India Institute of Medical Sciences, New Delhi
Outcome results
None listed