Docetaxel and Irinotecan in Gastric Cancer

Menoufia University

Status and phase: Completed; Phase 2

Conditions: Chemotherapy Effect; Gastric Cancer; Stomach Cancer

Treatments: Drug: Irinotecan; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT04770623

360

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Chemotherapy

Experimental group

Description:

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

Treatment:

Drug: Irinotecan

Drug: Docetaxel