Docetaxel and Irinotecan in Gastric Cancer

NCT ID: NCT04770623

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2023-01-09

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.

Conditions

Stomach Cancer; Gastric Cancer; Chemotherapy Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Docetaxel

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

Intervention Type: DRUG

Irinotecan

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Sohaib

Principal investigator, Lecturer of Clinical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Menoufia University, Faculty of medicine

Shibīn al Kawm, Menoufia, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 18971936 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26510663 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19209281 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17848736 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21742485 (View on PubMed)

Other Identifiers

360

Identifier Type: -

Identifier Source: org_study_id