Study on Ixazomib, Gemcitabine, and Doxorubicin for Treating Advanced or Metastatic Kidney Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03587662

Provider View

This clinical trial is testing a combination of three drugs—Ixazomib, Gemcitabine, and Doxorubicin—to see how well they work together in treating kidney cancer that has spread or is advanced. The study aims to find out if this combination can better control the cancer by stopping tumor growth and spread.

Patient Parameters

Program Overview

This study is exploring how well a combination of three drugs—Ixazomib, Gemcitabine, and Doxorubicin—works in treating kidney cancer that has spread to other parts of the body or is locally advanced. Ixazomib may help stop tumor growth by blocking certain enzymes needed for cell growth. Gemcitabine and Doxorubicin are chemotherapy drugs that work by killing cancer cells or stopping them from dividing and spreading. The study aims to see if using these drugs together is more effective in treating kidney cancer.

Description

The main goal of this study is to see how well the combination of Ixazomib, Gemcitabine, and Doxorubicin works in controlling kidney cancer that has spread or is advanced. Researchers will look at how many patients respond to the treatment and how long the cancer stays under control. They will also monitor overall survival, how long patients live without the cancer getting worse, and the safety of the treatment.

The study will also explore certain biological markers in the tumor and blood to understand how the treatment works and why some cancers might resist it.

Participants will receive the treatment in two phases:

  • Induction Phase: Patients take Ixazomib by mouth and receive Gemcitabine and Doxorubicin through an IV on the first day of each cycle. This phase repeats every 14 days for up to 13 cycles unless the cancer progresses or side effects become too severe.

  • Maintenance Phase: Patients continue with Ixazomib by mouth and Gemcitabine through an IV every 14 days for up to 2 years, again unless the cancer progresses or side effects become too severe.

After finishing the treatment, patients will have follow-up visits at 30 and 90 days, and then every 3 months.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic renal medullary carcinoma (RMC) or other rare SMARCB1-negative kidney tumors.
  • Can participate whether or not they have had kidney removal surgery.
  • Must have at least one measurable tumor that can be tracked by scans.
  • Can have had previous treatments, but not with certain combinations of Gemcitabine and Doxorubicin.
  • Must show evidence of cancer progression after the last treatment.
  • Be in good overall health with an ECOG performance status of 0-2.
  • Adolescents aged 12 and older can participate with parental consent.
  • Must meet specific blood count and organ function criteria.
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception.
  • Men must agree to use contraception if sexually active with women of childbearing potential.

Exclusion Criteria

  • Have another active cancer or have been treated for another cancer within the last 2 years, except for certain skin cancers.
  • Have received certain cancer treatments within 2 weeks before starting the study.
  • Have had major surgery or significant injury within 4 weeks before starting the study.
  • Have certain viral infections like HIV or active hepatitis B or C.
  • Have severe nerve damage or gastrointestinal issues that affect drug absorption.
  • Be taking certain medications that interact with the study drugs.
  • Have uncontrolled medical conditions or infections.
  • Have uncontrolled brain metastases or require ongoing steroid treatment for brain metastases.
  • Be pregnant or breastfeeding, or not using effective birth control if of reproductive potential.
  • Have allergies to any of the study drugs.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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