bortezomib in treating patients with unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma

Conditions: Gastric Cancer

Summary: rationale: bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. purpose: phase ii trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

objectives: primary * determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. secondary * determine the toxicity of this drug in these patients. * determine possible predictors of response to this drug, using pretreatment tumor immunohistochemistry, in these patients. outline: this is an open-label, nonrandomized, multicenter study. patients receive bortezomib iv over 3-5 seconds on days 1, 4, 8, and 11. courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 1 year. projected accrual: a total of 15-33 patients will be accrued for this study within 5-12 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma * siewert's class ii or iii disease * measurable disease * at least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques or at least 10 mm by spiral ct scan * no history of known or active brain metastases or primary brain tumors patient characteristics: age * 18 and over performance status * karnofsky 60-100% or * ecog 0-2 life expectancy * not specified hematopoietic * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin no greater than 1.5 mg/dl * ast and alt no greater than 3 times upper limit of normal (uln) (5 times uln if liver metastases are present) renal * creatinine no greater than 1.5 mg/dl cardiovascular * no prior cerebrovascular event * no prior orthostatic hypotension * no myocardial infarction within the past 6 months * no peripheral vascular disease requiring surgical management * no evidence of acute ischemia or significant conduction abnormality by ekg other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 2 months after study participation * no evidence of peripheral neuropathy * no prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib * no other malignancy within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or adequately treated nonmetastatic prostate cancer * no ongoing or active infection * no psychiatric illness or social situation that would preclude study participation * no other concurrent uncontrolled illness that would preclude study participation * no other medical condition or reason that would preclude study participation prior concurrent therapy: biologic therapy * more than 3 weeks since prior immunotherapy * no concurrent biological or immunological agents chemotherapy * no more than 1 prior chemotherapy regimen (including adjuvant chemotherapy) * more than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * no concurrent chemotherapy endocrine therapy * not specified radiotherapy * more than 3 weeks since prior radiotherapy * no concurrent radiotherapy surgery * not specified other * recovered from all prior therapy * no other concurrent investigational agents * no other concurrent anticancer agent or therapy

Keywords: recurrent gastric cancer stage iii gastric cancer stage iv gastric cancer adenocarcinoma of the stomach