Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02228681|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2014
Results First Posted : May 24, 2019
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced, Persistent, or Recurrent Endometrial Cancer||Drug: Everolimus Drug: Tamoxifen Drug: Letrozole Drug: Medroxyprogesterone Acetate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of Everolimus and Letrozole or Hormonal Therapy (Tamoxifen/Medroxyprogesterone Acetate) in Women With Advanced, Recurrent, or Persistent Endometria Carcinoma|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||January 2018|
Experimental: Everolimus and Letrozole
Everolimus 10 mg daily and Letrozole 2.5 mg PO daily
10mg daily by mouth
Other Name: RAD001
2.5mg twice a day by mouth
Other Name: Femara®
Active Comparator: Hormonal Therapy
Tamoxifen 20 mg PO BID; on alternating weeks (even numbered) weeks, Medroxyprogesterone Acetate 200 mg PO daily with Tamoxifen 20 mg PO BID
20 mg daily by mouth on alternating weeks (even numbered) weeks
Other Name: Nolvadex®
Drug: Medroxyprogesterone Acetate
200 mg daily by mouth
- Frequency of Response [ Time Frame: From date of randomization until the date of first documented progression or date of death , up to 3 years. ]A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- Median Progression-free Survival [ Time Frame: Tumor measurements were done at 8 and 16 weeks after initiating treatment and then every 12 weeks and compared with baseline measurements prior to treatment. Measurements are continued until disease progression is documented or death. ]Progression-free Survival is defined as the duration alive from study entry until progression is documented, or death; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.
- Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4 [ Time Frame: Assessed throughout the treatment period and for 30 days after discontinuation of treatment. Treatment continues until progression of disease. ]Maximum grade of physician assessed adverse events graded and categorized using Common Toxicity Criteria for Adverse Events (CTCAE) version 4
- Median Survival [ Time Frame: Following treatment discontinuation, patients are followed quarterly for 2 years, semi-annually for 3 more years, annually thereafter. ]Survival is defined as the duration alive from study entry until death.
- Hormone Receptor Immunohistochemistry [ Time Frame: At study entry ]To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for hormone receptor (estrogen receptor-alpha, estrogen receptor-beta, progesterone receptor-A, progesterone receptor B and the G protein-coupled estrogen receptor, GPR-30) immunohistochemistry.
- mTOR Pathway Immunohistochemistry [ Time Frame: At study entry ]To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for mTOR pathway (including phosphorylated S6 ribosomal protein, PTEN, total and phosphorylated AKT, total and phosphorylated mTOR, and phospho-ERK1/2) immunohistochemistry
- Mutation Analysis [ Time Frame: At study entry ]To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue and DNA extracted from whole blood will be used for mutational analysis (including PTEN, PIK3CA, KRAS, and CTNNB1 (beta-catenin) performed using a sequencing panel assay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228681
|Study Chair:||Brian Slomovitz, MD||Gynecologic Oncology Group|