Study on Pazopanib Hydrochloride for Patients with Metastatic Kidney Cancer with No Disease Signs After Surgery
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01575548
This clinical trial is testing whether the drug pazopanib hydrochloride can help prevent the return of kidney cancer that has spread to other parts of the body and shows no signs of disease after surgery. The study compares pazopanib to a placebo to see which is more effective in stopping cancer growth.
Patient Parameters
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Program Overview
The purpose of this study is to find out if pazopanib hydrochloride can help stop the growth of kidney cancer cells by blocking certain enzymes and blood flow to tumors. This trial is for patients whose kidney cancer has spread but shows no signs of disease after surgery. Participants will be randomly assigned to receive either pazopanib or a placebo to compare their effectiveness in preventing cancer recurrence.
Description
The main goal of this study is to see how long patients can remain free of kidney cancer after surgery when taking pazopanib compared to a placebo. Researchers will also look at overall survival rates, side effects, and quality of life during and after treatment. Patients will be randomly assigned to one of two groups: one group will take pazopanib daily, and the other will take a placebo. Both groups will undergo regular scans to monitor their health. After completing the treatment, patients will have follow-up visits every few months for up to 10 years to check for any signs of cancer returning.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have confirmed kidney cancer with a clear cell component and evidence of metastatic disease removed by surgery.
- Must have had surgery to remove the primary kidney tumor and any metastatic sites within 2-12 weeks before joining the study.
- Must have no signs of cancer on post-surgery imaging scans.
- Must have good overall health with an ECOG performance status of 0 or 1.
- Must have adequate blood counts and organ function based on specific lab tests.
- Women of childbearing potential must test negative for pregnancy and agree to use effective contraception during the study.
- Must be able to swallow pills and have no significant digestive issues.
- Must have controlled blood pressure and no recent history of stroke.
Exclusion Criteria
- Cannot have tumors only within the kidneys without other sites of disease.
- Cannot have received prior or concurrent systemic therapy for kidney cancer.
- Cannot have active peptic ulcer disease or inflammatory bowel disease.
- Cannot have significant heart failure or recent heart issues.
- Cannot have active central nervous system metastases.
- Cannot be pregnant or breastfeeding.
- Cannot have allergies to similar drugs as pazopanib.
- Cannot have uncontrolled illnesses or psychiatric conditions that affect study participation.
- Cannot have recent serious wounds or surgeries.
- Cannot be taking certain medications that interact with pazopanib.
- Cannot have a history of other cancers within the last 3 years, except for specific non-threatening types.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| University of Arizona Cancer Center-Orange Grove Campus | 85704 | Tucson | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| CHI Saint Vincent Cancer Center Hot Springs | 71913 | Hot Springs | Arkansas |
| PCR Oncology | 93420 | Arroyo Grande | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Epic Care-Dublin | 94568 | Dublin | California |
| Bay Area Breast Surgeons Inc | 94608 | Emeryville | California |
| Epic Care Partners in Cancer Care | 94608 | Emeryville | California |
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