Docetaxel and Irinotecan in Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04770623
• Other study ID #: 360
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 2021
• Est. completion date: January 9, 2023

Study information

• Verified date: January 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chemotherapy Effect
• Gastric Cancer
• Stomach Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	Menoufia University, Faculty of medicine	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Farhat 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. — View Citation

Shitara 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. — View Citation

Tetzlaff 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. — View Citation

Thuss-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	described according to RECIST criteria	6 months from chemotherapy
Secondary	Quality of life (QoL)	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
Secondary	Progression free survival (PFS)	The time interval between starting the test protocol and the next disease progression or death whichever earlier	One year from start of enrollment
Secondary	Overall survival (OS)	The time interval between diagnosis and death	One year from start of enrollment