Gastric Cancer
Conditions
Keywords
advanced gastric cancer, irinotecan, cisplatin
Brief summary
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.
Detailed description
Open label single arm phase II study of cisplatin and irinotecan in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 40 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: 8 cycles/14 days of irinotecan 125 mg/m2 on Day 1 and cisplatin 50 mg/m2 on Day2. This study will also include genotype investigations of UGT1A1 and ERCC1 expression in order to assess determinants of efficacy and toxicity of the treatment with cisplatin and irinotecan in the study population.
Interventions
irinotecan 125 mg/m2 will be administered as an intravenous (IV) infusion over half a hour on Days 1; Cisplatin 60 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day. 14 days as a cycle, up to 8 cycles.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to event efficacy | 1 year | 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 |
Countries
China
Outcome results
None listed