Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-008951
NCT ID: NCT01575548
Sponsor Protocol Number: E2810
About this study
This randomized phase III trial studies how well pazopanib hydrochloride works compared to placebo in treating patients with metastatic kidney cancer who have no evidence of disease after surgery. Pazopanib hydrochloride 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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastatectomy specimen
- Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past)
- Patient must have undergone surgical resection to remove one or more sites of metastatic disease, with successful removal of all known sites 2-12 weeks prior to randomization; any number of prior metastatectomies may have been performed in the past, so long as the most recent procedure was within the 12 weeks of registration; the most recent procedure may be nephrectomy for a renal primary tumor
- Patients with synchronous disease at initial diagnosis must have metastatic (M1) disease (American Joint Committee on Cancer [AJCC] 7th edition T1-4N0-1M1)
- Positive surgical margins are permitted if the surgeon confirms complete resection of gross metastatic disease, and post-operative scans are negative
- Patients presenting with metachronous disease may have distant metastases, regional lymph node or renal bed recurrence; recurrences at a partial nephrectomy resection site are not eligible if it is the only site of disease
- Patients presenting with tumors within the kidneys (multiple synchronous or single/multiple metachronous) are not eligible if there are no extrarenal sites of disease (i.e. potential multifocal primary disease)
- Patient must have no evidence of disease on post-operative imaging:
- A computed tomography (CT) of the chest must be obtained within 4 weeks prior to randomization with or without contrast
- A CT of the abdomen/pelvis must be obtained within 4 weeks prior to randomization with intravenous (IV) contrast (oral contrast may be added at the radiologist's discretion); an MRI of the abdomen/pelvis with gadolinium may be substituted for the CT if the CT with IV contrast is contra-indicated
- An MRI of the brain with and without gadolinium must be done within 8 weeks prior to randomization; a CT of the brain with and without IV contrast is permitted if MRI is contra-indicated (i.e., pacemaker)
- Patient must not have received any prior or concurrent systemic therapy for RCC; adjuvant placebo administration is permitted
- Patient must have no active peptic ulcer disease
- Patient must have no active inflammatory bowel disease
- Patient must have no New York Heart Association (NYHA) class II or greater congestive heart failure
- Patient must have no prior history or current clinically apparent central nervous system metastases
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of randomization
- Absolute granulocyte count > 1,500/mcL
- Platelets > 100,000/mcL
- Total bilirubin < 1.5 times institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) < 2.5 times upper limit of normal (ULN)
- Calculated creatinine clearance (CrCl) > 30 mL/min
- Subjects must have a urine protein/creatinine (UPC) ratio < 1; if UPC ≥ 1, then a 24-hour urine total protein must be obtained; subjects must have a 24-hour urine protein value < 1g to be eligible; use of urine dipstick for renal function assessment is not acceptable
- Women must not be pregnant or breast-feeding Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately
- Patient must be able to swallow pills and have no significant impairment in gastrointestinal absorption including history of gastric bypass surgery
- Patient must have no history of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib
- Patient must have no uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) ≤ 0.48 seconds by Bazett's calculation (≤ Common Terminology Criteria for Adverse Events [CTCAE] v.4 Grade 2) prior to randomization
- Patient must have a systolic blood pressure ≤ 140 mmHg and diastolic blood pressure must be ≤ 90 mmHg, measured within 4 weeks prior to randomization; initiation or adjustment of anti-hypertensives prior to starting study treatment is allowed
- Patient must not have serious or non-healing wound, ulcer, or bone fracture at the time of randomization
- Patient must have no history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to randomization
- Patient must have no history of cerebrovascular accident (CVA) within 6 months of randomization
- Patient must have no history of myocardial infarction, hospital admission for unstable angina, cardiac angioplasty or stenting within 6 months of randomization
- Patient must have no history of venous thrombosis within 12 weeks of randomization
- Patient cannot be taking strong CYP3A4 inhibitors such as:
- Antibiotics: clarithromycin, telithromycin, troleandomycin
- Human immunodeficiency virus (HIV) antiviral protease inhibitors: ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir
- Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole
- Antidepressants: nefazodone
- Patient must not have history of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to randomization
- Patient must not be taking drugs known to prolong the QTc interval; such drugs should be discontinued at least 5 half-lives prior to randomization
- Patients must not have any history of other cancer within 3 years from time of randomization with the exception of basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or resected non-invasive (Ta) urothelial carcinoma
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Brian Costello, M.D.
Open for Enrollment
Cancer Center Clinical Trials Referral Office