drugset / Trial / NCT03760822
Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients
Phase 2
Active not recruiting
112 enrolled
Federation Francophone de Cancerologie Digestive
Eli Lilly and Company · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed. The co-primary endpoints are the following: * Six months survival rate * Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future
Timeline
- Start
- 2018-11-16
- Primary completion
- 2024-12
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Ramucirumab | Monoclonal antibody | 8 mg/kg | Intravenous |