Docetaxel and Irinotecan in Gastric Cancer
Docetaxel and Irinotecan Combination as a Second Line Treatment of Metastatic Gastric Cancer; a Phase II Study
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedStudy Start
First participant enrolled
March 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2023
CompletedJanuary 30, 2024
January 1, 2024
1.8 years
February 19, 2021
January 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate (ORR)
described according to RECIST criteria
6 months from chemotherapy
Secondary Outcomes (3)
Quality of life (QoL)
three months and six months from chemotherapy
Progression free survival (PFS)
One year from start of enrollment
Overall survival (OS)
One year from start of enrollment
Study Arms (1)
Chemotherapy
EXPERIMENTALSecond 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
Interventions
patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who received docetaxel or irinotecan before recruitment to this study
- Multiple comorbid conditions
- Liver or kidney impairment
- Severe cachexia (sarcopenia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Menoufia University, Faculty of medicine
Shibīn al Kawm, Menoufia, 32511, Egypt
Related Publications (5)
Catalano V, Graziano F, Santini D, D'Emidio S, Baldelli AM, Rossi D, Vincenzi B, Giordani P, Alessandroni P, Testa E, Tonini G, Catalano G. Second-line chemotherapy for patients with advanced gastric cancer: who may benefit? Br J Cancer. 2008 Nov 4;99(9):1402-7. doi: 10.1038/sj.bjc.6604732.
PMID: 18971936BACKGROUNDShitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.
PMID: 26510663BACKGROUNDTetzlaff ED, Cheng JD, Ajani JA. Review of docetaxel in the treatment of gastric cancer. Ther Clin Risk Manag. 2008 Oct;4(5):999-1007. doi: 10.2147/tcrm.s3226.
PMID: 19209281BACKGROUNDFarhat FS. A general review of the role of irinotecan (CPT11) in the treatment of gastric cancer. Med Oncol. 2007;24(2):137-46. doi: 10.1007/BF02698032.
PMID: 17848736BACKGROUNDThuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.
PMID: 21742485BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, Lecturer of Clinical oncology
Study Record Dates
First Submitted
February 19, 2021
First Posted
February 25, 2021
Study Start
March 5, 2021
Primary Completion
January 9, 2023
Study Completion
January 9, 2023
Last Updated
January 30, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Sharing the data will be after publishing the primary results, expected to be by the end 0f 2022
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.