Back to resultsStudy of Cetuximab to Treat Gastric Cancer (STAGE)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Time to Progression, Toxicity, Overall survival, Response rate, Quality of live
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- ECOG performance scale ≤ 1
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- Adequate hepatic, renal, heart, and hematologic functions (platelets>80 × 109/L, neutrophil>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)
Exclusion Criteria:
- Pregnant or lactating women
- Concurrent cancer
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Neuropathy, brain, or leptomeningeal involvement
- Uncontrolled significant comorbid conditions and previous radiotherapy
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
administer cetuximab in combination with modified FOLFIRI
Outcomes
Primary Outcome Measures
time to progression
Secondary Outcome Measures
toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00699881
Brief Title
Study of Cetuximab to Treat Gastric Cancer
Acronym
STAGE
Official Title
Phase II Study of Cetuximab (Erbitux®) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-line Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy
Detailed Description
Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of cetuximab combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a second line treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Time to Progression, Toxicity, Overall survival, Response rate, Quality of live
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
administer cetuximab in combination with modified FOLFIRI
Intervention Type
Drug
Intervention Name(s)
cetuximab
Other Intervention Name(s)
treatment group
Intervention Description
cetuximab 400mg/m2 as initial dose, subsequently at 250mg/m2 weekly dose. CPT-11 180 mg/m2 CF 200 mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle
Primary Outcome Measure Information:
Title
time to progression
Time Frame
every 8 weeks
Secondary Outcome Measure Information:
Title
toxicity
Time Frame
every 8 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
ECOG performance scale ≤ 1
At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
Adequate hepatic, renal, heart, and hematologic functions (platelets>80 × 109/L, neutrophil>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)
Exclusion Criteria:
Pregnant or lactating women
Concurrent cancer
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Neuropathy, brain, or leptomeningeal involvement
Uncontrolled significant comorbid conditions and previous radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, PhD, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
ShangHai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28288572
Citation
Liu X, Guo W, Zhang W, Yin J, Zhang J, Zhu X, Liu T, Chen Z, Wang B, Chang J, Lv F, Hong X, Wang H, Wang J, Zhao X, Wu X, Li J. A multi-center phase II study and biomarker analysis of combined cetuximab and modified FOLFIRI as second-line treatment in patients with metastatic gastric cancer. BMC Cancer. 2017 Mar 14;17(1):188. doi: 10.1186/s12885-017-3174-z.
Results Reference
derived
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Study of Cetuximab to Treat Gastric Cancer
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