Clinical trial NCT04770623: Docetaxel and Irinotecan in Gastric Cancer
Official title: Docetaxel and Irinotecan Combination as a Second Line Treatment of Metastatic Gastric Cancer; a Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Cancer
Gastric Cancer
Chemotherapy Effect
Keywords: gastric
stomach
docetaxel
irinotecan
chemotherapy
second line
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients from multiple oncology centers across Egypt are recruited for this study. Second line treatment of advanced gastric cancer will be tested with irinotecan and docetaxel combination
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 6 months from chemotherapy
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: three months and six months from chemotherapy
measure: Progression free survival (PFS)
timeFrame: One year from start of enrollment
measure: Overall survival (OS)
timeFrame: One year from start of enrollment
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University, Faculty of medicine
state: Menoufia
Study officials:
References:
citation: 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.
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.
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.
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.
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.