NCT02684227

Enzalutamide, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrioid Endometrial Cancer

A Phase II Study With a Limited Safety Lead-In of Enzalutamide in Combination With Carboplatin and Paclitaxel in Advanced Stage or Recurrent Endometrioid Endometrial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well enzalutamide, carboplatin, and paclitaxel work in treating patients with endometrioid endometrial cancer that is stage III-IV or has come back. Androgens can cause the growth of endometrioid endometrial cancer. Antihormone therapy, such as enzalutamide may lessen the amount of androgen made by the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving enzalutamide, carboplatin, and paclitaxel may work better in treating patients with endometrioid endometrial cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the clinical activity of combination enzalutamide, carboplatin and paclitaxel represented as: Ia. Objective tumor response (complete response \[CR\] + partial response \[PR\]). Ib. The proportion of patients who survive progression-free for at least 6 months after initiating therapy. II. To quantify protein and phosphoprotein expression of androgen receptor (AR) and AR-response genes following enzalutamide treatment in match-paired pre and post treatment tumor biopsies. III. To determine the safety and feasibility of daily enzalutamide given in combination with carboplatin and paclitaxel in women with advanced stage or recurrent endometrial cancer. SECONDARY OBJECTIVES: I. Determine median response duration. II. Estimate progression free survival and overall survival. III. Evaluate for presence of pharmacokinetic interaction between enzalutamide and paclitaxel. EXPLORATORY OBJECTIVES: I. Correlate molecular results, including AR receptor expression and activation, to clinical endpoints. II. Identify potential agents to synergize with enzalutamide based on pathways activated after enzalutamide treatment. OUTLINE: Patients receive enzalutamide orally (PO) once daily (QD) alone on days 1-28. Patients then receive enzalutamide PO QD on days 1-21, paclitaxel intravenously (IV) over 3 hours on day 1, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6-9 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Conditions

• Recurrent Endometrial Endometrioid Adenocarcinoma
• Recurrent Uterine Corpus Carcinoma
• Stage III Uterine Corpus Cancer AJCC v7
• Stage IIIA Uterine Corpus Cancer AJCC v7
• Stage IIIB Uterine Corpus Cancer AJCC v7
• Stage IIIC Uterine Corpus Cancer AJCC v7
• Stage IV Uterine Corpus Cancer AJCC v7
• Stage IVA Uterine Corpus Cancer AJCC v7
• Stage IVB Uterine Corpus Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Enzalutamide	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Paclitaxel	Given IV
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2016-08-24
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2016-02-17
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study