Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

Conditions

• Endometrial Adenocarcinoma
• Endometrial Adenosquamous Carcinoma
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Recurrent Malignant Uterine Corpus Neoplasm
• Stage IIIA Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
• Stage IIIB Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
• Stage IIIC Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
• Stage IVA Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
• Stage IVB Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Carboplatin — DRUG
  Given IV
• Ixabepilone — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Paclitaxel — DRUG
  Given IV
• Temsirolimus — DRUG
  Given IV

Study Details

This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which treatment regimen is most effective in treating patients with endometrial cancer.

Key Dates

First listed

Sep 15, 2009

Start date

Sep 14, 2009

Status verified

Mar 2026

Primary completion

Jan 31, 2015

Completion

Mar 6, 2027

Study Design

Enrollment

349 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (paclitaxel, carboplatin, bevacizumab)
  Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (paclitaxel, carboplatin, temsirolimus)
  Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm III (ixabepilone, carboplatin, bevacizumab)
  Patients receive ixabepilone IV over 1 hour, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants Who Progressed or Died by 25 Months From Enrollment [ Time Frame: at 25 months ]

Locations (230)

Find similar trials in Phoenix, AZ

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