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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 April 2013 |
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Main ID: |
NCT01238055 |
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Date of registration:
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07/01/2010 |
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Primary sponsor: |
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Public title:
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Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer
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Scientific title:
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Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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116 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01238055 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jeeyun Lee, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Samsung Medical Center, Seoul, Korea |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or
gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the
stomach)
2. 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
3. prior chemotherapy wit fluoropyrimidine and platinum
4. measurable or evaluable disease according to RECIST
5. age, 18 years or older
6. ECOG performance status 0 - 2
7. 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
8. life expectancy of = 3 months
9. signed written informed consent
Exclusion Criteria:
1. more than one prior chemotherapy for metastatic disease
2. severe co-morbid illness and/or active infections
3. NCI CTCAE Grade 3 hemorrhage from any cause < 4 weeks before enrollment
4. preexisting uncontrolled hypertension as documented by 2 baseline blood pressure
readings taken at least 1 hour apart
5. pregnant or lactating women
6. active CNS metastases not controllable with radiotherapy or corticosteroids
7. active and uncontrollable bleeding from gastrointestinal tract
8. known history of hypersensitivity to study drugs
9. prior treatment with sunitinib
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Gastric Cancer
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Intervention(s)
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Drug: Docetaxel + Sunitinib
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Drug: Docetaxel only
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Primary Outcome(s)
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time to progression
[Time Frame: every 6 weeks]
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Secondary Outcome(s)
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Overall survival
[Time Frame: 12 months]
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Progression free survival
[Time Frame: 12 months]
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Response rate
[Time Frame: 12 months]
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Secondary ID(s)
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2008-09-031
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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