Everolimus for Kidney Cancer
(S0931 Trial)

Recruiting in Palo Alto (17 mi)

+1002 other locations

Overseen byChristopher W. Ryan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: SWOG Cancer Research Network

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.

Research Team

Christopher W. Ryan, MD

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for adults who've had surgery for kidney cancer, with no remaining or spreading cancer detectable by CT/MRI scans. They should be in good physical condition (Zubrod status 0-1), have proper organ function, and not be pregnant. Participants must use effective contraception and be able to take oral medications. Those with heart disease, severe liver impairment, HIV, uncontrolled diabetes or cholesterol levels, allergies to everolimus components, or other recent cancers are excluded.

Inclusion Criteria

My kidney cancer has spread to small blood vessels but not to distant parts.

My condition is classified as intermediate high-risk or very high-risk.

I have had surgery to remove my kidney and any affected lymph nodes.

See 16 more

Exclusion Criteria

I have unstable chest pain.

I have severe heart disease.

I have not had a heart attack in the last 6 months.

See 18 more

Treatment Details

Interventions

Everolimus (mTOR inhibitor)

Trial OverviewThe study is testing the effectiveness of Everolimus in preventing kidney cancer from returning after surgery. Patients will either receive Everolimus or a placebo (a pill without active medication) to compare outcomes between the two groups.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm IExperimental Treatment1 Intervention

Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm IIPlacebo Group1 Intervention

Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.