Advanced Gastric Cancer
Conditions
Keywords
advanced gastric cancer, sunitinib, docetaxel, fluoropyrimidine platinum based chemotherapy
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 platinum.
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.
Interventions
DRUGDocetaxel + Sunitinib
Docetaxel 60 mg/m2 iv, every 3 weeks Sunitinib 37.5 mg qd daily, every 3 weeks
DRUGDocetaxel only
Docetaxel 60 mg/m2 iv
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progression | every 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | 12 months |
| Overall survival | 12 months |
| Progression free survival | 12 months |
Countries
South Korea
Outcome results
None listed