NCT04770623

Docetaxel and Irinotecan in Gastric Cancer

Docetaxel and Irinotecan Combination as a Second Line Treatment of Metastatic Gastric Cancer; a Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The primary end point is response rate. Secondary end points are toxicity, PFS and OS.

Detailed description

Gastric cancer is a major killer in oncology. The expected overall survival of metastatic patients is less than 2 years. Moreover, most of the patients develop cachexia and worsening of performance over time. As a result, many patients are not fit for second line treatment when eligible. There is currently no approved consensus for third line treatment regimen and in most of the patients it is usually best supportive care. Irinotecan and docetaxel were tested as single agents or in combination with other drugs (e.g. FOLFIRI) in second line setting. However, the combination of these two drugs together was not tested before. Both agents are active in second line setting which is considered the last chance of the patient in view of lack of evidence in third line setting.

Conditions

• Stomach Cancer
• Gastric Cancer
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Docetaxel	patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
DRUG	Irinotecan	patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival

Timeline

• Start date: 2021-03-05
• Primary completion: 2023-01-09
• Completion: 2023-01-09
• First posted: 2021-02-25
• Last updated: 2024-01-30

Locations

1 site across 1 country: Egypt