Docetaxel and Irinotecan in Gastric Cancer

January 26, 2024 updated by: Ahmed Sohaib, Menoufia University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt, 32511
        • Menoufia University, Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QoL)
Time Frame: 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.
three months and six months from chemotherapy
Progression free survival (PFS)
Time Frame: One year from start of enrollment
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)
Time Frame: One year from start of enrollment
The time interval between diagnosis and death
One year from start of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

January 9, 2023

Study Completion (Actual)

January 9, 2023

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 360

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Sharing the data will be after publishing the primary results, expected to be by the end 0f 2022

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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