Study on Pazopanib Hydrochloride and Bevacizumab for Treating Metastatic Kidney Cancer
Sponsor: Roswell Park Cancer Institute
ClinicalTrials ID:NCT01684397
This clinical trial is testing the safety and effectiveness of a combination of two drugs, pazopanib hydrochloride and bevacizumab, in patients with kidney cancer that has spread to other parts of the body and has not been treated before.
Patient Parameters
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Program Overview
This study aims to find the best dose and understand the side effects of combining two drugs, pazopanib hydrochloride and bevacizumab, to treat kidney cancer that has spread (metastatic). Pazopanib hydrochloride works by blocking enzymes needed for cancer cell growth and cutting off blood supply to tumors. Bevacizumab, a monoclonal antibody, helps prevent tumor growth by stopping cancer cells from growing and spreading. The combination of these drugs may be more effective in killing cancer cells.
Description
The study is divided into two phases: Phase I and Phase II.
In Phase I, the main goal is to find a safe dose of the drug combination. Researchers will also look at how the body processes pazopanib and how it affects certain blood markers related to cancer.
In Phase II, the focus is on how well the treatment works in stopping cancer from growing or spreading. Researchers will also monitor the safety and side effects of the treatment, as well as overall survival rates.
Participants will take pazopanib hydrochloride by mouth daily for 28 days and receive bevacizumab through an IV on specific days. This cycle repeats every 70 days unless the cancer progresses or side effects become too severe.
After finishing the treatment, participants will have follow-up visits to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of clear cell renal cell carcinoma (CCRCC) that has spread to other parts of the body.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood counts and organ function, including:
- Hemoglobin level of at least 10 gm/dL.
- Neutrophil count of at least 1.5 x 10^9/L.
- Platelet count of at least 100 x 10^9/L.
- Normal liver function tests.
- Normal kidney function or creatinine clearance above 30 mL/min.
- Normal heart function with an ejection fraction above 50%.
- Have measurable cancer according to standard criteria.
- Be able to swallow and retain oral medication.
- Agree to use effective contraception during the study and inform the doctor immediately if pregnancy is suspected.
- Understand the study and agree to sign informed consent.
Exclusion Criteria
- Have known brain metastases.
- Have received prior VEGF-targeted therapies for kidney cancer, except for specific cases in Phase I.
- Have been diagnosed with another cancer in the past 3 years, except for certain skin cancers.
- Be using another anti-cancer drug or investigational agent.
- Have had major surgery within 28 days before starting treatment or plan major surgery in the next 6 months.
- Have uncontrolled illnesses or conditions that would interfere with the study.
- Have a history of certain heart conditions or uncontrolled high blood pressure.
- Have had a blood clot in the past 6 months.
- Be currently on blood thinners or have a bleeding disorder.
- Be pregnant or breastfeeding.
- Be unable or unwilling to follow study requirements.
- Have received an investigational agent within 30 days before joining the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| Karamanos Cancer Institute | 482018 | Detroit | Michigan |
| Roswell Park Cancer Institute | 14263 | Buffalo | New York |
| University of Pittsburgh Cancer Institute (UPCI) | 15232 | Pittsburgh | Pennsylvania |
| Medical College of Wisconsin | 53226 | Milwaukee | Wisconsin |
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