Clinical trial · Interventional
Docetaxel and Irinotecan in Gastric Cancer
Docetaxel and Irinotecan Combination as a Second Line Treatment of Metastatic Gastric Cancer; a Phase II Study
NCT04770623CI-TRIAL-00073430completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- description
- 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
- interventionNames
- Drug: Docetaxel
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- 6 months from chemotherapy
- description
- described according to RECIST criteria
Secondary outcomes (3)
- measure
- Quality of life (QoL)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (5)
- BACKGROUNDCatalano 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 18971936
- BACKGROUNDShitara 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 26510663
- BACKGROUNDTetzlaff 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 19209281
- BACKGROUNDFarhat 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 17848736
- BACKGROUNDThuss-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 21742485