START Trial: Testing Two-Drug Combinations for Metastatic Kidney Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01217931

Provider View

This study is exploring different combinations of two drugs to see how they affect metastatic kidney cancer. Participants will receive one drug and may switch to another if needed. The study also looks at the safety of these drug combinations.

Patient Parameters

Program Overview

The START Trial is a research study aimed at finding the best sequence of two-drug combinations for treating metastatic kidney cancer. The drugs being tested are everolimus, bevacizumab, and pazopanib. Participants will receive one of these drugs and may switch to another if their cancer worsens. The study will also monitor the safety of these drug combinations.

Description

The study involves three drugs:

  • Everolimus: This drug aims to stop cancer cells from growing, which may lead to their death.
  • Bevacizumab: This drug works by blocking the growth of blood vessels that feed tumors, potentially slowing or stopping cancer growth.
  • Pazopanib: This drug targets a protein that can cause tumors to grow uncontrollably, helping to prevent cancer from spreading.

How the Study Works:

Participants will be randomly assigned to one of six groups, each receiving a different sequence of the drugs:

  • Group 1: Pazopanib, possibly followed by bevacizumab.
  • Group 2: Pazopanib, possibly followed by everolimus.
  • Group 3: Everolimus, possibly followed by bevacizumab.
  • Group 4: Everolimus, possibly followed by pazopanib.
  • Group 5: Bevacizumab, possibly followed by pazopanib.
  • Group 6: Bevacizumab, possibly followed by everolimus.

If the first drug doesn't work, participants may switch to the second drug after 2-4 weeks, provided there are no severe side effects.

Drug Administration:

  • Everolimus: Taken by mouth once daily.
  • Bevacizumab: Given by vein every two weeks.
  • Pazopanib: Taken by mouth once daily on an empty stomach.

Study Visits and Tests:

  • Weekly blood pressure checks during the first month if taking pazopanib or bevacizumab.
  • Bi-weekly urine tests if receiving bevacizumab.
  • Monthly physical exams, blood tests, and side effect assessments.
  • CT scans every 8 weeks to monitor cancer status.
  • Annual MRI of the brain and heart health checks.

Participation Duration:

Participants will continue treatment as long as it is beneficial and side effects are manageable. Follow-up visits will occur every few months for up to five years after treatment ends.

End-of-Treatment and Follow-Up:

After stopping the study drugs, participants will have a final check-up and regular follow-ups to monitor their health and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic kidney cancer with a clear cell component.
  • Have had kidney surgery or tumor treatment.
  • Have measurable cancer.
  • Aged 18 or older.
  • Good overall health and organ function.
  • Women must have a negative pregnancy test and use birth control.
  • Able to swallow pills.
  • Willing to provide informed consent.

Exclusion Criteria

  • Have another active cancer.
  • Have received prior targeted therapy or chemotherapy for kidney cancer.
  • Have multiple brain metastases.
  • Have had a stroke or heart attack within 6 months.
  • Have uncontrolled infections or high blood pressure.
  • Pregnant or breastfeeding women.
  • Have significant heart or liver disease.
  • Taking certain medications that interact with study drugs.

Locations

FACILITYZIPCITYSTATE
University of Texas MD Anderson Cancer Center77030HoustonTexas

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