Bortezomib in Treating Patients With Metastatic Kidney Cancer (NCT00276614) | Clinical Trial Compass
CompletedPhase 2
Bortezomib in Treating Patients With Metastatic Kidney Cancer
United States4 participantsStarted 2006-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses