Phase 2
N=50
Enzalutamide, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrioid Endometrial Cancer
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
Bottom Line
View on ClinicalTrials.gov: NCT02684227 ↗Enrolled (actual)
50
Serious AEs
12.0%
Results posted
Mar 2025
Primary outcome: Primary: Clinical Activity of Combination Enzalutamide, Carboplatin and Paclitaxel Represented as Objective Tumor Response (Complete Response (CR) + Partial Response (PR)). — 68; 62 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin (Drug); Enzalutamide (Drug); Laboratory Biomarker Analysis (Other); Paclitaxel (Drug); Pharmacological Study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Activity of Combination Enzalutamide, Carboplatin and Paclitaxel Represented as Objective Tumor Response (Complete Response (CR) + Partial Response (PR)). |
68; 62 | — |
| PRIMARY 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 |
0; 2; 3; 3 | — |
| PRIMARY Median Duration of Progression-free Survival |
14.23; 13.27 | — |
| SECONDARY Overall Survival |
NA; 36.14 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients must have a histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of advanced stage (stage III or IV) or recurrent endometrioid endometrial cancer
- Measurable disease (at least one measurable lesion) IS required; a measurable lesion is one that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be > 10 mm when measured by computed tomography (CT) scan, magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or > 20 mm when measured by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or MRI
- Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST); tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patient with an Eastern Cooperative Oncology Group (ECOG) performance status = = 1,500/mcl, equivalent to Common Terminology Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03) grade 1
- Platelets >= 100,000/mcl
- Calculated creatinine clearance (Cockcroft-Gault formula) > 50 ml/min OR 24-hour urine creatinine clearance > 50 ml/min
- Bilirubin = = 160/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus; screening for chronic conditions is not required
- As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
Data sourced from ClinicalTrials.gov (NCT02684227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.