Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: PS-341 in Treating Patients With Metastatic 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.

Detailed description: 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: 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

Relevance to patient case: not relevant