Back to resultsIrinotecan as 3rd Line Therapy in Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Chemotherapy, metastatic gastric cancer, irinotecan
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
Sites / Locations
- Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Irinotecan
Arm Description
In the experimental arm, patients receive single agent of irinotecan as third line treatment in metastatic gastric cancer.
Outcomes
Primary Outcome Measures
Overall Survival
From the day enrolled in the study to death
Secondary Outcome Measures
Progression free survival
Objective Response Rate
evaluated by RECIST 1.1
Number of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02662959
Brief Title
Irinotecan as 3rd Line Therapy in Gastric Cancer
Official Title
A Phase II Study of Irinotecan as Single Agent in the Third Line Treatment of Unresectable or Metastatic Gastric Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Chemotherapy, metastatic gastric cancer, irinotecan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Irinotecan
Arm Type
Experimental
Arm Description
In the experimental arm, patients receive single agent of irinotecan as third line treatment in metastatic gastric cancer.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
180 mg/m2, IV (in the vein) on day 1 of each 14 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Overall Survival
Description
From the day enrolled in the study to death
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
6 month
Title
Objective Response Rate
Description
evaluated by RECIST 1.1
Time Frame
8 weeks
Title
Number of Adverse Events
Time Frame
Participants will be followed for the duration of treatment interval, an expected average of two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZHIYU CHEN, M.D.
Phone
+862164175590
Email
zychan75@163.com
Facility Information:
Facility Name
Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyu Chen, MD
First Name & Middle Initial & Last Name & Degree
Weijian Guo, MD
12. IPD Sharing Statement
Learn more about this trial
Irinotecan as 3rd Line Therapy in Gastric Cancer
We'll reach out to this number within 24 hrs