Study on Ixazomib Citrate with Gemcitabine and Doxorubicin for Treating Advanced Urothelial Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02420847

Provider View

This clinical trial is testing a combination of three drugs—Ixazomib Citrate, Gemcitabine, and Doxorubicin—to find the best dose and check for side effects in patients with urothelial cancer that has spread or cannot be removed by surgery.

Patient Parameters

Program Overview

The purpose of this study is to determine the safest and most effective dose of a new drug combination for treating urothelial cancer that has spread or cannot be surgically removed. The drugs being tested are Ixazomib Citrate, which may stop cancer cells from growing, and two chemotherapy drugs, Gemcitabine and Doxorubicin, which work by killing cancer cells or stopping them from spreading. The study aims to see if this combination can be a better treatment option for patients with advanced urothelial cancer.

Description

This study is divided into two phases. In Phase I, researchers will find the highest dose of the drug combination that patients can tolerate without severe side effects. In Phase II, they will test this dose to see how well it works in shrinking tumors and improving survival in patients with advanced urothelial cancer.

Participants will receive Ixazomib Citrate orally, and Gemcitabine and Doxorubicin through an IV on the first day of each treatment cycle. These cycles will repeat every 14 days as long as the cancer does not progress and side effects are manageable.

The study will also evaluate the side effects of the treatment and determine the best dose to use in future studies. Researchers will monitor the response rate and survival of patients to assess the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of urothelial cancer that has spread or cannot be removed by surgery.
  • Have measurable or evaluable disease, such as tumors in the liver or lungs that are at least 1 cm in size.
  • Have received at least one prior therapy, unless unable or unwilling to receive cisplatin-based therapy.
  • For Phase I, any number of previous treatments is allowed.
  • For Phase II, previous treatments must not include certain drugs like bortezomib or high doses of gemcitabine and adriamycin.
  • Have a heart function test showing an ejection fraction of at least 45% if there is a history of heart disease or high exposure to doxorubicin.
  • Have liver enzyme levels within specified limits.
  • Have an ECOG performance status of 2 or less, or 3 if due to cancer symptoms.
  • Agree to use effective contraception during the study and for 90 days after the last dose.
  • Provide written informed consent to participate in the study.

Exclusion Criteria

  • Have a low platelet count or low neutrophil count.
  • Have poor kidney function with creatinine clearance below 30 mL/min.
  • Have severe nerve damage or pain.
  • Have high bilirubin levels.
  • Have allergies to any study medications.
  • Be pregnant or breastfeeding.
  • Be participating in another clinical trial within 30 days of starting this trial.
  • Have significant heart disease or recent heart attack.
  • Have active brain metastases unless stable and treated.
  • Have had recent radiation therapy or major surgery.
  • Have another active cancer or infection.
  • Have serious medical or psychiatric conditions that could interfere with the study.
  • Have gastrointestinal issues that affect drug absorption.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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