Health Condition 1: C499- Malignant neoplasm of connective and soft tissue, unspecified
Conditions
Interventions
Intervention1: Gemcitabine and docetaxel chemotherapy drug regimen:
Dose: Injection gemcitabine 900mg/m2 (days 1 and 8), Injection docetaxel 75mg/m2 (day 1) on 21 day cycle
Frequency: Gemcitabine (
Sponsors
Department of Medical Oncology
Eligibility
Inclusion criteria
Inclusion criteria: a) Age 15-75 years b) Synovial sarcoma confirmed histologically c) Metastatic/unresectable locally advanced disease, relapsed post 1st line of chemotherapy d) ECOG Performance status (PS) �2 e) Absolute Neutrophil Count >1000/mcl, Hemoglobin >8.0g/dL, Platelet > 1,00,000/mcL f) Creatinine 60ml/min g) Total bilirubin less than institutional upper limit of normal, ALT and AST
Exclusion criteria
Exclusion criteria: a) Age less than 15 or more than 75 years b) Pregnant or breast feeding patient c) Active or uncontrolled infection d) Locally recurrent disease which is amenable to curative surgical resection e) Prior therapy taken for the synovial sarcoma with gemcitabine-docetaxel combination e) Documented history of taxane hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) rateTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival (OS) 2. Response rates ââ?¬â?? Complete response (CR), Partial response (PR), Stable disease (SD) 3. Safety 4. Quality of life (QoL) analysis Timepoint: 3 month, plus total duration of study for OS calculation (24 months) | — |
Countries
India
Contacts
Public ContactDr Sameer Rastogi
All India Institute of Medical Sciences, Delhi
Outcome results
None listed