Study on Weekly Doxorubicin for Elderly Patients with Advanced or Metastatic Leiomyosarcoma

Sponsor: University of Colorado, Denver

Sponsor score: 40

ClinicalTrials ID:NCT07125183

Provider View

This clinical trial is testing a lower dose of the chemotherapy drug doxorubicin, given weekly, to see if it is effective and easier to tolerate for elderly patients with advanced or metastatic leiomyosarcoma, a type of cancer that cannot be removed by surgery.

Patient Parameters

Program Overview

The aim of this Phase 2 study is to find out if a lower dose of doxorubicin, given weekly, can effectively treat leiomyosarcoma in patients aged 65 to 100 years. Doxorubicin is a standard treatment for this type of cancer, but older patients may have difficulty handling its side effects. This study will measure how long patients live without the cancer getting worse over 12 weeks, and also look at quality of life and side effects. Researchers will also study how the treatment affects the immune system and the cancer itself by analyzing blood and tumor samples.

Description

This study is open to up to 30 patients with advanced or metastatic leiomyosarcoma, aiming to have 20 patients complete the study. It uses a special design to decide if the treatment is working well enough to continue. The main goal is to see if the cancer stays stable for 12 weeks. If 65% of patients have stable disease at 12 weeks, the treatment will be considered promising. The study will also look at how long patients live without the cancer getting worse, how well the cancer responds to treatment, and any side effects or changes in quality of life.

Patients will receive doxorubicin at a dose of 25 mg/m2, given by injection, along with a protective drug called dexrazoxane on days 1 and 8 of a 21-day cycle, for up to 8 cycles. A growth factor called pegfilgrastim will be given on day 9 to help the body make more blood cells. Scans to check the cancer will be done every 6 weeks during treatment and every 12 weeks after treatment for up to a year. Patients will have regular blood tests, check-ups, and heart tests to monitor for side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be able to sign a consent form and agree to follow study procedures.
  • Aged 65 to 100 years.
  • Diagnosed with advanced or metastatic leiomyosarcoma that cannot be removed by surgery.
  • Have measurable or evaluable cancer.
  • Have had 0 to 4 previous treatments for metastatic sarcoma, but no prior treatment with anthracyclines.
  • Have good organ function and a performance status of 0, 1, or 2.
  • Agree to have tumor biopsies at specific times during the study.
  • Men must use contraception during and after the study; women must be post-menopausal or have had surgery to remove reproductive organs.
  • Must have or be willing to have a central venous catheter placed.

Exclusion Criteria

  • Previous treatment with anthracyclines.
  • Allergic to doxorubicin or its ingredients.
  • Currently taking other investigational drugs.
  • Recent chemotherapy, targeted therapy, or radiation therapy within 21 days before starting the study.
  • Have another active cancer needing treatment, except for certain skin cancers or in situ cervical cancer.
  • Have immune deficiencies, chronic infections, or a history of HIV or tuberculosis.
  • Have blood disorders or recent blood clots that are not stable.
  • Have active brain metastases or certain brain conditions.
  • Have received a live vaccine recently.
  • Have uncontrolled illnesses, heart problems, or psychiatric conditions that could interfere with the study.
  • Have a prolonged QT interval on an EKG or low heart function.

Locations

FACILITYZIPCITYSTATE
University Of Colorado Hospital80045AuroraColorado

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