Back to resultsSorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
sorafenib
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, Toxicities
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- ECOG performance scale ≤ 2
- 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)
- 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 sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent
Outcomes
Primary Outcome Measures
time to progression
Secondary Outcome Measures
toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00595985
Brief Title
Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
Official Title
Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
low response rate, no evidence of PFS or OS improved.
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
January 2009 (Anticipated)
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 tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).
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 sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib 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, Toxicities
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
sorafenib
Other Intervention Name(s)
treatment group
Intervention Description
sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Primary Outcome Measure Information:
Title
time to progression
Time Frame
every six weeks
Secondary Outcome Measure Information:
Title
toxicity
Time Frame
6 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 ≤ 2
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)
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
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
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