Docetaxel and Irinotecan in Gastric Cancer

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Stomach Cancer, Gastric Cancer, Chemotherapy Effect

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy<br>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 | Drug: Docetaxel<br>* patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival<br>Drug: Irinotecan<br>* patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | described according to RECIST criteria | 6 months from chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QoL) | 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. | three months and six months from chemotherapy | 
| Progression free survival (PFS) | The time interval between starting the test protocol and the next disease progression or death whichever earlier | One year from start of enrollment | 
| Overall survival (OS) | The time interval between diagnosis and death | One year from start of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric, stomach, docetaxel, irinotecan, chemotherapy, second line