Colon Cancer 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.
Full 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 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
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There are 10 Locations for this study
Chicago Illinois, 60637, United States
Chicago Illinois, 60640, United States
Decatur Illinois, 62526, United States
Harvey Illinois, 60426, United States
LaGrange Illinois, 60525, United States
Maywood Illinois, 60153, United States
Peoria Illinois, 61602, United States
Fort Wayne Indiana, 46885, United States
South Bend Indiana, 46617, United States
Saint Joseph Michigan, 49085, United States
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