Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.

Inclusion criteria

• 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 criteria

• 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