Docetaxel and Irinotecan in Gastric Cancer

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

Patients from multiple oncology centers across Egypt are recruited for this study. Second line treatment of advanced gastric cancer will be tested with irinotecan and docetaxel combination

Second line treatment will be as follows Docetaxel at 30 mg/m2 over 500 cc normal saline over 1 hour infusion Irinotecan at 185 mg/m2 with a maximum of 300 mg given over 500 cc normal saline over 2 hours infusion The whole regimen is to be cycled every 2 weeks for a maximum of 6 months with interim and end of treatment evaluation

patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival

patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival

A questionnaire with the QLQ-C30 form will be conducted at enrollment, after 3 months and after end of treatment. A score between 1 to 4 will be used in the questionnaire where higher score means worse quality of life.

The time interval between starting the test protocol and the next disease progression or death whichever earlier

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)

Investigators of this study agreed to share IPD for free with any other investigators with the following conditions: Sharing the data will be after publishing the primary results Other studies using our data should submit our names as sub-investigators when publishing their results.

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