Docetaxel and Irinotecan in Gastric Cancer

Sponsor
Menoufia University
Study ID
NCT04770623
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 5, 2021
Status verified
Jan 2024
Primary completion
Jan 9, 2023
Completion
Jan 9, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 6 months from chemotherapy ]

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