ps-341 in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. it is not yet known which regimen of ps-341 is more effective in treating metastatic kidney cancer. purpose: randomized phase iii trial to study the effectiveness of ps-341 in treating patients who have metastatic kidney cancer.

objectives: * determine the objective response rate in patients with metastatic renal cell cancer treated with bortezomib. * determine the time to tumor progression and 1-year survival of patients treated with this drug. * determine the toxicity profile of this drug in these patients. outline: this is a randomized, multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive bortezomib iv over 3-5 seconds twice weekly on weeks 1 and 2. treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. patients then undergo core biopsy. * arm ii: patients undergo core biopsy. patients then receive bortezomib iv as in arm i. patients undergo radiologic re-evaluation of measurable lesions. patients with stable disease or a partial or complete response continue to receive bortezomib in the absence of disease progression or unacceptable toxicity. patients are followed for 2 years. projected accrual: a total of 21-41 patients will be accrued for this study within 9-14 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed metastatic renal cell cancer * measurable disease * at least 2.0 cm in at least 1 dimension by physical exam or at least 1.0 cm in at least 1 dimension by radiologic exam * single measurable lesion must not be within prior radiotherapy portal * tumor lesion amenable to core biopsy * at least 1 cm of tumor obtainable * no active cns metastatic disease * single previously resected cns metastasis allowed provided no disease progression 8 weeks after therapy and no longer requiring steroids or antiseizure medications patient characteristics: age: * 18 and over performance status: * not specified life expectancy: * more than 3 months hematopoietic: * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast/alt no greater than 2.5 times uln renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia other: * no other uncontrolled concurrent illness * no ongoing or active infection * no psychiatric illness or social situation that would preclude study compliance * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier-method contraception during and for 3 months after study participation prior concurrent therapy: biologic therapy: * prior immunotherapy or biotherapy allowed chemotherapy: * no prior chemotherapy endocrine therapy: * see disease characteristics radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy * no prior radiotherapy to 25% or more of bone marrow (i.e., whole pelvis) surgery: * see disease characteristics other: * no other concurrent investigational agents * no concurrent combination antiretroviral therapy for hiv-positive patients

Keywords: stage iv renal cell cancer recurrent renal cell cancer