NCT02023593

FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

Phase Ⅱ Study of FOLFIRI as Second-Line Chemotherapy for Metastatic Esophageal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Yuhong Li · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal carcinoma.

Detailed description

Although there are no standard second-line treatment for metastatic esophageal carcinoma, some studies have showed that irinotecan, fluorouracil may be effective in treating patients with metastatic esophageal carcinoma after failure of first-line treatment. Since irinotecan, fluorouracil, and leucovorin work in different ways to stop the growth of tumor. Giving more than one drug may be more effective. In this phase Ⅱ trial, the investigator would like to observe the efficacy and safety of FOLFIRI(Irinotecan/5-FU/leucovorin ) as second-line treatment for metastatic esophageal carcinoma.

Conditions

• Advanced Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	FOLFIRI	Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.

Timeline

• Start date: 2012-03-01
• Primary completion: 2019-12-01
• Completion: 2022-12-01
• First posted: 2013-12-30
• Last updated: 2023-02-16

Locations

1 site across 1 country: China