Docetaxel and Irinotecan in Gastric Cancer

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

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.

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.

Inclusion Criteria:

• Histopathological evidence of adenocarcinoma of the stomach
• Metastatic disease or locally advanced non-resectable disease
• Patients who received only one line of treatment
• Performance status 0,1,2 as per ECOG scoring system

Exclusion Criteria:

• Patients who received docetaxel or irinotecan before recruitment to this study
• Multiple comorbid conditions
• Liver or kidney impairment
• Severe cachexia (sarcopenia)