Completed

A Phase II Study of CCI-779 in Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

temsirolimus

+ laboratory biomarker analysis
Drug
Other
Who is being recruted

Urogenital Diseases
+23

+ Genital Diseases
+ Adenocarcinoma
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To assess the efficacy (response rate \& duration of stable disease) of CCI-779 (temsirolimus) given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. II. To assess the adverse events, time to progression and response duration of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. III. To correlate objective tumor response with phosphatase and tensin homolog gene (PTEN) expression in the tumor tissue obtained at diagnosis (primary tumor). IV. To explore the relationship between objective tumor response with other molecular measures in diagnostic tumor tissue. OUTLINE: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.

Official TitleA Phase II Study of CCI-779 in Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer 
NCT00072176
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
62 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Genital Diseases
Adenocarcinoma
Carcinoma
Cystadenocarcinoma
Female Urogenital Diseases and Pregnancy Complications
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes
Recurrence
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Endometrial Neoplasms
Neoplasms, Complex and Mixed
Carcinoma, Adenosquamous
Adenocarcinoma, Clear Cell
Cystadenocarcinoma, Serous
Neoplasms, Cystic, Mucinous, and Serous
Disease Attributes
Female Urogenital Diseases
Adenomyoepithelioma
Criteria

Inclusion Criteria: * Patients must have histologically confirmed metastatic and/or locally advanced recurrent adenocarcinoma (papillary serous, papillary, villoglandular, mucinous, clear cell), endometrioid or adenosquamous carcinoma of the endometrium, incurable by standard therapies * Patients must have tumour tissue from their primary tumor available to assess molecular markers of CCI-779 activation (paraffin block or unstained slides) * Presence of clinically and/or radiologically documented disease; at least one site of disease must be unidimensionally measurable as follows: * X-ray, physical exam \>= 20 mm * Spiral computed tomography (CT) scan \>= 10 mm * Non-spiral CT scan \>= 20 mm * All radiology studies must be performed within 28 days prior to registration (within 35 days if negative) * Patients must have a life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 * Previous therapy: * Hormonal therapy: * Group A: One prior hormonal treatment (progestational or aromatase inhibitor) as either adjuvant therapy or for treatment of metastatic disease * Group B: No limit to number of prior hormonal treatments given (progestational or aromatase inhibitor) as either adjuvant therapy or for treatment of metastatic disease * Time since last hormone: \>= 1 week since last dose of hormonal therapy (applies to both Groups) * Chemotherapy: * Group A: No prior chemotherapy * Group B: Patients must have had one prior regimen of chemotherapy for metastatic disease; patients must be 4 weeks since last dose of chemotherapy * Radiation: Patients may have had prior radiation therapy; a minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study; (exceptions may be made however, for low dose, palliative radiotherapy; patients must have recovered from any acute toxic effects from radiation prior to registration * Previous surgery: Previous major surgery is permitted provided that it has been at least 21 days prior to patient registration and that wound healing has occurred * Granulocytes (absolute granulocyte count \[AGC\]) \>= 1.5 x 10\^9/L * Platelets \>= 100 x 10\^9/L * Bilirubin =\< upper normal limit (UNL) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x UNL * Serum creatinine =\< 1.5 x UNL or creatinine clearance \>= 50 ml/min; creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula * Fasting serum cholesterol =\< 9.0 mmol/L * Fasting triglycerides =\< 4.56 mmol/L * Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements; it will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Study Coordinator that such clearance has been obtained, before the trial can commence in that centre; because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given; a copy of the initial full board Research Ethics Board (REB) approval and approved consent form must be sent to the central office; the patient must sign the consent form prior to randomization or registration; please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records * Patients must be accessible for treatment and follow-up; patients registered on this trial must be treated and followed at the participating center; this implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial; investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up * In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient registration Exclusion Criteria: * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \>= 5 years * Patients must not have had prior treatment with an mammalian target of rapamycin (mTOR) inhibitor * Uterine sarcomas (leiomyosarcoma), mixed mullerian tumours (MMT) and/or adenosarcomas * Patients with non-measurable disease only; (please note that bone metastases are considered non-measurable) * Pregnant or lactating women; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with CCI-779; most patients enrolled on this trial will have had a prior hysterectomy or pelvic irradiation; however, if the patient is of childbearing potential, a urine beta-human chorionic gonadotropin (HCG) must be proved negative within 7 days prior to registration; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Patients with known brain metastases; (a head CT is not necessary to rule out brain metastases, unless there is clinical suspicion of central nervous system \[CNS\] involvement) * Patients with serious cardiovascular illness such as myocardial infarction within 6 months prior to entry, congestive heart failure (even if medically controlled), unstable angina, active cardiomyopathy, unstable ventricular arrhythmia or uncontrolled hypertension * History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 * Patients receiving concurrent treatment with other anti-cancer therapy or other investigational agents * Serious illness or medical condition which would not permit the patient to be managed according to the protocol including, but not limited to: * History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements * Active uncontrolled infection * Active peptic ulcer disease * Any other medical conditions that might be aggravated by treatment


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Given IV

Correlative studies
Study Objectives
Primary Objectives

Defined as proportion of patients with 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response) and confirmed on independent radiology review.

Time to tumor progression or death

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Cancer Institute of Canada Clinical Trials GroupKingston, CanadaSee the location

CompletedOne Study Center
;