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.
Drug: irinotecan and cisplatin
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Locations near you
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Full eligibility criteria for NCT01444521
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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).
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
All locations for NCT01444521
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
View full eligibility
Tris trial is registered with FDA with number: NCT01444521. The sponsor of the trial is Chinese Academy of Medical Sciences and it is looking for 50 volunteers for the current phase.
Official trial title: Genotype-drive Phase II Study of Novel Irinotecan-Cisplatin Combination as First-line Therapy for Advanced Gastric Cancer
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