Study on Chemotherapy and Immunotherapy Combinations for Advanced or Recurrent Endometrial Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT00977574

Provider View

This clinical trial is testing different combinations of chemotherapy and immunotherapy drugs to find the most effective treatment for patients with advanced or recurrent endometrial cancer. The study aims to determine which combination best controls the cancer and improves patient outcomes.

Patient Parameters

Program Overview

This study is exploring three different treatment combinations for patients with advanced or recurrent endometrial cancer. The treatments include chemotherapy drugs like paclitaxel, carboplatin, and ixabepilone, and immunotherapy drugs like bevacizumab and temsirolimus. These drugs work in various ways to stop cancer cells from growing and spreading. The goal is to find out which combination is most effective in treating this type of cancer.

Description

The study is divided into three treatment groups:

  • Group 1: Patients receive paclitaxel, carboplatin, and bevacizumab. After six cycles, patients continue with bevacizumab alone if the cancer has not progressed.
  • Group 2: Patients receive paclitaxel, carboplatin, and temsirolimus. After six cycles, patients continue with temsirolimus alone if the cancer has not progressed.
  • Group 3: Patients receive ixabepilone, carboplatin, and bevacizumab. After six cycles, patients continue with bevacizumab alone if the cancer has not progressed.

The study will monitor how well each treatment works in controlling the cancer and how long patients live without the cancer getting worse. It will also look at the side effects of each treatment and how they affect patients' quality of life. Patients will be followed up regularly for up to five years after completing the study therapy.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or recurrent endometrial cancer that can be measured by scans or exams.
  • Have a specific type of endometrial cancer confirmed by a lab test.
  • Be in good overall health with a performance status score of 0, 1, or 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Have not received prior chemotherapy or targeted therapy for endometrial cancer.
  • Have not received prior therapy with bevacizumab, temsirolimus, or similar drugs.
  • May have received prior radiation or hormonal therapy, but must have completed it at least four weeks before starting the study.
  • Agree to sign an informed consent form and allow the release of personal health information for the study.

Exclusion Criteria

  • Have had another invasive cancer within the last three years, except for certain skin cancers.
  • Have received prior radiation or chemotherapy for other abdominal or pelvic tumors within the last three years.
  • Have serious, non-healing wounds or active bleeding disorders.
  • Have uncontrolled high blood pressure or significant heart disease.
  • Have a history of severe allergic reactions to similar drugs.
  • Are pregnant or nursing.

Locations

FACILITYZIPCITYSTATE
Saint Joseph's Hospital and Medical Center85013PhoenixArizona
Mayo Clinic in Arizona85259ScottsdaleArizona
University of Arizona Cancer Center-North Campus85719TucsonArizona
Providence Saint Joseph Medical Center/Disney Family Cancer Center91505BurbankCalifornia
John Muir Medical Center-Concord94520ConcordCalifornia
UC San Diego Moores Cancer Center92093La JollaCalifornia
UCLA / Jonsson Comprehensive Cancer Center90095Los AngelesCalifornia
Palo Alto Medical Foundation-Gynecologic Oncology94040Mountain ViewCalifornia
UC San Diego Medical Center - Hillcrest92103San DiegoCalifornia
San Diego VA Medical Center92161San DiegoCalifornia

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