| General information |
| Database: | DB00874 |
| Objective: | Thisphase II trial investigates the efficacy and safety of lowdose everolimus in combination with cisplatinfluorouracil chemotherapy in patients with advanced gastric cancer. |
| Authors: | Shen YC, et al |
| Title: | Phase II multicentered study of lowdose everolimus plus cisplatin and weekly 24hour infusion of highdose 5fluorouracil and leucovorin as firstline treatment for patients with advanced gastric cancer. |
| Journal: | Oncology. |
| Year: | 2014 |
| PMID: | 25011938 |
| Trial Design |
| Clinical Trial Id: | NCT00632268 |
| Agent: | everolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | gastric cancer |
| Cancer Subtype: | advanced gastric cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | everolimus + cisplatin |
| Study Type: | Phase II multicentered study |
| Key Patients Feature: | patients with chemotherapyna ve advanced gastric cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received lowdose everolimus (10 mg p.o. on days 1, 8 and 15) plus cisplatin and a weekly 24hour infusion of highdose 5fluorouracil and leucovorin (HDFL) chemotherapy (cisplatin 35 mg/m(2) intravenous infusion for 24 h on days 1 and 8, 5fluorouracil 2, 000 mg/m(2) and leucovorin 300 mg/m(2) intravenous infusion for 24 h on days 1, 8 and 15) every 28 days. |
| Primary End Point: | objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors version 1.0 |
| Secondary End Point: | NA |
| Patients Number: | 40 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 52.50% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.9 (95% CI, 4.98.4) months |
| Median OS A vs. C: | 10.5 (95% CI, 8.612.3) months |
| Adverse Event(agent arm): | The most common (more than and equal to 50%) AEs were anemia (72.5%), nausea (60.0%), leukopenia (57.5%), thrombocytopenia (55.5%), neutropenia (52.5%), vomiting (52.5%), and constipation (50.0%). The most common (>5%) AEs of grade 3 or 4 were hyponatremia (22.5%), neutropenia (20.0%), anemia (15.0%), anorexia (15.0%), thrombocytopenia (12.5%), hypokalemia (12.5%), and diarrhea (7.5%). Most of the AEs were considered primarily chemotherapyrelated. Two patients (5.0%) died of pneumonia (first cycle) and sepsis (sixth cycle), respectively. |
| Conclusions: | Adding lowdose everolimus to cisplatinHDFL chemotherapy failed to increase the ORR as in a preplanned statistical assumption but may prolong progression free survival in treatmentna?ve advanced gastric cancer patients. |