Clinical trial · Interventional
Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer
Genotype-drive Phase II Study of Novel Irinotecan-Cisplatin Combination as First-line Therapy for Advanced Gastric Cancer
NCT01444521CI-TRIAL-00014432completedPhase 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)
The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal dosage of combination chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single-arm Irinotecan-Cisplatin
- interventionNames
- Drug: irinotecan and cisplatin
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 1 year
- description
- The primary objective of this study is to determine the response rate of CPT11 plus cisplatin as first-line therapy in patients with advanced gastric carcinoma.
Secondary outcomes (1)
- measure
- Time to event efficacy
- timeFrame
- 1 year
- description
- The secondary objectives of this study are to evaluate: The following time to event efficacy measures: * Duration of overall response for responding patients * Time to documented progressive disease * Overall survival * The quantitative and qualitative toxicity of irinotecan plus cisplatin. * Determinants of efficacy and toxicity of the treatment with irinotecan and cisplatin in the patient population by means of pharmacogenomic investigations: Quantitative analysis of UGT1A1 and ERCC1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven diagnosis of adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction) * Stage III or Stage IV disease, according to American Joint Committee on Cancer criteria * Patients with UGT1A1\*28 genotype 6/6 or 6/7 * Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale * Previous adjuvant or pre-operative chemotherapy without containing irinotecan or platinum at least 6 months before enrollment * Adequate organ function including the following: Bone marrow: absolute neutrophil count (ANC) \>or equal to 1.5 \* 109/L, platelets \>or equal to 100 \*109/L, hemoglobin \> or equal to 10 g/dL. Hepatic: bilirubin \< or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin \> or equal to3g/dL. Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula). Exclusion Criteria: * No Prior palliative chemotherapy for advanced disease * Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment * Known or suspected brain metastasis * Second primary malignancy
References
Publications (2)
- RESULTKoizumi W, Kurihara M, Satoh A, Takiuchi H, Tanabe S, Shimada K, Iwasaki R, Saigenji K. Phase 1/11 study of bi-weekly irinotecan plus cisplatin in the treatment of advanced gastric cancer. Anticancer Res. 2005 Mar-Apr;25(2B):1257-62. PMID 15865075
- RESULTSatoh T, Ura T, Yamada Y, Yamazaki K, Tsujinaka T, Munakata M, Nishina T, Okamura S, Esaki T, Sasaki Y, Koizumi W, Kakeji Y, Ishizuka N, Hyodo I, Sakata Y. Genotype-directed, dose-finding study of irinotecan in cancer patients with UGT1A1*28 and/or UGT1A1*6 polymorphisms. Cancer Sci. 2011 Oct;102(10):1868-73. doi: 10.1111/j.1349-7006.2011.02030.x. Epub 2011 Aug 12. PMID 21740478