Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer, recurrent renal cell cancer, papillary renal cell carcinoma
Brief summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer.
Detailed description
OBJECTIVES: Primary * Determine, preliminarily, the efficacy of bortezomib in patients with metastatic non-clear cell renal cell carcinoma in terms of objective response rate after a minimum of 2 courses of treatment. Secondary * Correlate clinical response in these patients with baseline von Hippel-Lindau expression and nuclear factor-KB activity. OUTLINE: This is an open-label study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month and then periodically for 2 years. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Interventions
DRUGbortezomib
Sponsors
Millennium Pharmaceuticals, Inc.
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed pure non-clear cell renal cell carcinoma (RCC) * Distant metastatic disease (Tx, Nx, M1) * Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein * Measurable disease on imaging scan (≥ 1 cm) * Brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy. * Life expectancy ≥ 3 months * Karnofsky performance status ≥ 60% * Negative pregnancy test * Fertile patients must use an acceptable method of contraception * No other major illnesses likely to limit survival * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1, 000/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusion allowed) * Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL * ALT or AST ≤ 2.5 times upper limit of normal * At least 4 weeks since prior radiotherapy and recovered * More than 30 days since any other prior investigational drugs
Exclusion criteria
* active CNS metastases * pregnant or nursing * myocardial infarction within the past 6 months * New York Heart Association class III or IV heart failure * uncontrolled angina * severe uncontrolled ventricular arrhythmias * electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Peripheral neuropathy ≤ grade 1 * hypersensitivity to bortezomib, boron, or mannitol * history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of the skin * serious medical or psychiatric illness that would preclude study participation * prior cytotoxic chemotherapy for this cancer * other concurrent investigational therapy * concurrent chemotherapy, immunotherapy, or hormonal therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses | 2 months |
Countries
United States
Participant flow
Recruitment details
Recruitment period from April 2006 through May 2009 at outpatient oncology clinic.
Participants by arm
| Arm | Count |
|---|---|
| Bortezomib Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Progression of disease under study | 3 |
Baseline characteristics
| Characteristic | Bortezomib |
|---|---|
| Age, Continuous | 42 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses
Time frame: 2 months
Population: 2 subjects were excluded from analysis as they completed less than 2 cycles of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bortezomib | Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses | 2 participants |