Docetaxel and Irinotecan in Gastric Cancer

Menoufia University32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stomach Cancer Gastric Cancer Chemotherapy Effect

Interventions

DocetaxelDRUG

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

IrinotecanDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Menoufia University, Faculty of medicine

Shibīn al Kawm, Menoufia, Egypt

Outcomes

Primary Outcomes

Overall response rate (ORR)

described according to RECIST criteria

Time frame: 6 months from chemotherapy

Secondary Outcomes

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.

Time frame: 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

Time frame: One year from start of enrollment

Overall survival (OS)

The time interval between diagnosis and death

Time frame: One year from start of enrollment

Data from ClinicalTrials.gov

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