Docetaxel and Irinotecan in Gastric Cancer

Phase 2

Completed

• Conditions: Chemotherapy Effect; Stomach Cancer; Gastric Cancer
• Interventions: Drug: Docetaxel; Drug: Irinotecan

• Registration Number: NCT04770623
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-25
• Study Start: 2021-03-05
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Docetaxel	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
Chemotherapy	Irinotecan	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

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	6 months from chemotherapy	described according to RECIST criteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Menoufia University, Faculty of medicine; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt