Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum

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.

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:

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