RAD001 in Recurrent Endometrial Cancer Patients

NCT00087685 | Completed Phase 2 Results

• 2 other identifiers: 2004-0002NCI-2012-01308
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer. The safety of this drug will also be studied. Objectives: Primary Objective: 1\. To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial cancer. Secondary Objective:

1. 1.To determine the nature and degree of toxicity of RAD001 in this cohort of patients.
2. 2.To characterize, in pre- and post- treatment tumor samples, when available, expression levels of total and phosphorylated mTOR (mammalian "target of rapamycin") as well as relevant upstream and downstream signaling components (optional).

Conditions

Endometrial Cancer

Keywords

Recurrent Endometrial Cancer; Endometrial; Endometrioid; RAD001; Uterine Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)

  Response determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Stable Disease (SD): Any condition not meeting the above criteria. The minimum duration for the SD will be 8 weeks. If the participant has stable disease at the time of the first radiographic evaluation, he/she will be considered to have stable disease. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

  8 weeks

• Clinical Benefit Rate

  Clinical benefit rate (CBR) is defined as the objective response rate plus the proportion of participants with prolonged stable disease (SD), e.g. nonprogression at 20 weeks. Objective response rate (ORR), determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST).

  20 weeks

Study Arms (1)

RAD001

EXPERIMENTAL

RAD001 10 mg by mouth Daily

Drug: RAD001

Interventions

RAD001 DRUG

10 mg by mouth Daily

RAD001

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed progressive or recurrent endometrial cancer (endometrioid or mixed with endometrioid component histology; any grade).
• Patients may have failed no more than two prior chemotherapies for the recurrent disease (does not include chemosensitizing radiation).
• All patients must have measurable disease. Measurable disease is defined as lesions that can be measured by physical examination or by means of imaging techniques. Ascites and pleural effusions are not considered measurable disease.
• Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of \>/=1,500/Fl, a hemoglobin level of \>/=9.0 gm/dL and a platelet count of \>/=100,000/Fl.
• Patients must have an adequate renal function as documented by serum creatinine \</=2.0 mg/dL.
• Patients must have adequate hepatic function as documented by a serum bilirubin \</=1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase (SGOT) must be \</=3x institutional upper limit of normal unless the liver is involved with tumor, in that case the aspartate transaminase must be \</=5x institutional upper limit of normal.
• Patients must have a Zubrod performance status of 0, 1, or 2.
• Patients must have signed an approved informed consent.

You may not qualify if:

• Patients who have previously received RAD001 or another mammalian target of rapamycin (mTOR) inhibitor.
• Patients whose tumors have serous carcinomas, mixed malignant mullerian tumors (MMMT) components or uterine sarcomas.
• Patients who have isolated recurrences (vaginal, pelvic, or para-aortic) that are amenable to potentially curative treatment with radiation therapy or surgery.
• Patients with a history of psychiatric disorders that would interfere with consent or follow-up.
• Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
• Patients with a history of prior malignancy (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer) or other cancer for which the patient has been disease-free for at least five years.
• Pregnant or lactating women. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
• Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.
• Patients with any other severe concurrent disease which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
• Patients with deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of study entry.
• Patients with \>/= grade 2 hypercholesterolemia or hypertriglyceridaemia (fasting state), despite lipid lowering therapy should be excluded from entering the study.
• Patients currently taking any of the medications listed in Appendix A (Patients will be given a listing of these medications at the time of the informed consent).
• Known hypersensitivity to everolimus, sirolimus or excipients including hydroxytoluene, magnesium stearate, hydroxypropylmethyl-cellulose, crospovidone and lactulose.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Karen H. Lu, MD, Chair, Gynecologic Oncology & Reproductive Medicine
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-745-8902

Study Officials

• Karen H. Lu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2004
• First Posted: July 14, 2004
• Study Start: June 1, 2004
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 1, 2025
• Results First Posted: February 5, 2016

Record last verified: 2025-04

Locations

US (1)