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Monoclonal Antibodies

Pazopanib + Bevacizumab for Kidney Cancer

Phase 1 & 2

Waitlist Available

Led By Saby George

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to swallow and retain oral medication

Biopsy/pathology-proven clear cell renal cell carcinoma (CCRCC) with metastases

Must not have

History of any of the following cardio-vascular condition: Myocardial infarction (MI), Unstable angina, Coronary artery bypass grafting (CABG)-unless patient had a negative stress test within 6 months of screening, Coronary angioplasty or stenting, Symptomatic peripheral arterial disease (PAD), History of symptomatic chronic congestive heart failure (CHF), History of cerebrovascular accidents including transient ischemic attacks (TIA), Corrected QT interval (QTc) > 480 msec, Uncontrolled hypertension (systolic blood pressure [BP] > 150 mm Hg or diastolic BP of > 90 mm Hg); if the screening BP is elevated, adjustments in anti-hypertensives are permitted and a re-screening will be permitted for BP assessment with three consecutive values obtained 2 minutes apart; the 3 values have to be below 150/90 mm Hg for eligibility and can only be obtained after 2 days of the last change in anti-hypertensive medication; use of clonidine is not permissible for adjusting the BP during this period, History of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 6 months, Subjects should not have packed red blood cells (PRBC) or platelet transfusion within 14 days of the screening, Evidence of active bleeding or bleeding disorder, Subjects currently on anti-coagulation therapy are not eligible, Unable to discontinue the use of prohibited medications, Pregnant or nursing female subjects, Unwilling or unable to follow protocol requirements, Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug, Received an investigational agent within 30 days prior to enrollment

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dosage of two drugs, pazopanib hydrochloride and bevacizumab, to treat patients with metastatic kidney cancer that has not been previously treated. 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. Bevacizumab is a monoclonal antibody that can prevent tumor growth by blocking the ability of tumor cells to grow and spread. Giving pazopanib hydrochloride together with bevacizumab may kill more tumor

Who is the study for?

This trial is for adults with clear cell renal cell carcinoma that has spread, who are in good physical condition (ECOG <=1), have not had certain other cancers or major surgeries recently, and do not have brain metastases or serious cardiovascular conditions. They must be able to take oral medication and agree to use birth control if of childbearing potential.

What is being tested?

The study is testing the combination of Pazopanib Hydrochloride, a drug that may block tumor growth by inhibiting enzymes and blood flow to the tumor, with Bevacizumab, an antibody that can prevent tumors from growing. The phase I/II trial aims to determine the best dose and how well these drugs work together against metastatic kidney cancer.

What are the potential side effects?

Possible side effects include high blood pressure, fatigue, diarrhea, changes in hair color, nausea or vomiting. More severe risks involve liver problems like hepatitis B reactivation or liver failure; heart issues such as heart failure; bleeding events; thyroid dysfunction; wound healing complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow and keep down pills.

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My kidney cancer has spread and was confirmed by a biopsy.

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I am fully active and can carry on all pre-disease activities without restriction.

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My kidney function is normal or meets the required levels.

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My heart pumps well, with an ejection fraction over 50%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any ongoing illnesses that would stop me from following the study's requirements.

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I haven't had major surgery in the last 28 days and don't plan any in the next 6 months.

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I do not have brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median PFS (Phase II)

Optimal phase II dose, defined as the largest dose level at which less than 2 out of the 6 patients experienced dose-limiting toxicity, graded according to Common Terminology Criteria for Adverse Events version 4.0 (Phase I)

Secondary study objectives

Incidence of grade 3 or higher toxicities, graded according to CTCAE version 4.0

Overall survival (Phase II)

PFS rate at 12 months (Phase II)

Other study objectives

IL-8 levels

MDSC levels

VEGF levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pazopanib hydrochloride and bevacizumab)Experimental Treatment4 Interventions

Patients receive pazopanib hydrochloride PO on days 1-28 and bevacizumab IV over 30-90 minutes on days 36 and 50. Courses repeat every 70 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pazopanib Hydrochloride

2009

Completed Phase 2

~820

Bevacizumab

2013

Completed Phase 4

~5540