Irinotecan as 3rd Line Therapy in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable or metastatic disease at the time of diagnosis. Systemic therapy was required for the patients with advanced stage. Platinum combined with fluoropyrimidines always were considered as first line treatment. After failure of initial therapy, single agent of taxanes was used as second line treatment. However, there is no relative standard chemotherapeutic regimen in the third therapy except oral anti-angiogenesis drug-Apatinib. So this study was designed to explore the role of single agent with irinotecan as third line treatment in patients with metastatic gastric cancer in China.

Official Title
-----------------
A Phase II Study of Irinotecan as Single Agent in the Third Line Treatment of Unresectable or Metastatic Gastric Cancer.

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Drug: Irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed advanced or metastatic adenocarcinoma of the stomach Have failed for 2 lines of chemotherapy Life expectancy of more than 3 months ECOG performance scale ≤ 2 At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan) Duration from the last therapy is more than 6 weeks for nitroso or mitomycin More than 4 weeks for operation or radiotherapy More than 4 weeks for cytotoxic agents or growth inhibitors Adequate hepatic, renal, heart, and hematologic functions (platelets > 100 × 109/L, neutrophil > 1.5× 109/L, serum creatinine ≤ 1×upper limit of normal(ULN), total bilirubin within 1× ULN, and serum transaminase≤2.5×the ULN). Exclusion of pregnant or lactating women Exclusion Criteria: Previously receiving irinotecan treatment Participated other clinical trials within 4 weeks Known Gilbert Syndrome or other biliary tract obstructive disease History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Evidence of CNS metastasis Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure Receiving the therapy of thrombolysis or anticoagulation Disability of serious uncontrolled intercurrence infection. Uncontrolled pleural effusion and ascites

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irinotecan<br>In the experimental arm, patients receive single agent of irinotecan as third line treatment in metastatic gastric cancer. | Drug: Irinotecan<br>* 180 mg/m2, IV (in the vein) on day 1 of each 14 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | From the day enrolled in the study to death | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 6 month | 
| Objective Response Rate | evaluated by RECIST 1.1 | 8 weeks | 
| Number of Adverse Events |  | Participants will be followed for the duration of treatment interval, an expected average of two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemotherapy, metastatic gastric cancer, irinotecan