Status:
COMPLETED
Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinu...
Detailed Description
This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.
Eligibility Criteria
Inclusion
- histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with \> 50% extension in the stomach)
- patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
- prior chemotherapy wit fluoropyrimidine and platinum
- measurable or evaluable disease according to RECIST
- age, 18 years or older
- ECOG performance status 0 - 2
- adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 2.0 mg/dL
- life expectancy of ≥ 3 months
- signed written informed consent
Exclusion
- more than one prior chemotherapy for metastatic disease
- severe co-morbid illness and/or active infections
- NCI CTCAE Grade 3 hemorrhage from any cause \< 4 weeks before enrollment
- preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids
- active and uncontrollable bleeding from gastrointestinal tract
- known history of hypersensitivity to study drugs
- prior treatment with sunitinib
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01238055
Start Date
November 1 2008
End Date
October 1 2012
Last Update
April 9 2013
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea