Endometrial CancerPhase 2ENDORADNCT00870337
Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer
A Phase 2 study testing everolimus in people with Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the endometrium
- Metastatic disease after first- or second-line chemotherapy
- Previously treated with platinum-based therapy in the adjuvant or metastatic setting
- Must have ≥ 1 measurable metastatic lesion outside previously irradiated areas
- No locally recurrent resectable tumor
- No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- ANC ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Transaminases ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other cancer within the past 3 years except for curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma
- No concurrent serious and/or uncontrolled disease that would preclude study participation, including any of the following:
- Uncontrolled diabetes
- Uncontrolled hypertension
- Severe infection
- Profound malnutrition
- Unstable angina
- NYHA class III-IV congestive heart failure
- Ventricular arrhythmia
- Coronary artery disease
- Myocardial infarction within the past 6 months
- Liver disease
- Chronic renal failure
- Progressive ulceration of the upper gastrointestinal tract
- No hypersensitivity to everolimus, sirolimus, or lactose
- No abnormalities ≥ grade 3
- No psychological, familial, social, or geographical reasons that would preclude study follow-up
- No history of poor compliance to medical treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior experimental drugs (e.g., mTOR inhibitors)
- More than 21 days since prior and no other concurrent chemotherapy, hormonal therapy, or antitumor therapy
- More than 5 days since prior strong CYP3A4 inhibitors or inducers (e.g., rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, or telithromycin)
- More than 30 days since other prior treatments
- No concurrent participation in another clinical trial that would interfere with the objectives of this study
- No concurrent anticoagulation, except for 1 mg of coumadin per day or low molecular weight heparin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer.
Read the detailed description
OBJECTIVES:
Primary
- Estimate the rate of non-progression after 3 months of treatment with everolimus in patients with relapsed or metastatic endometrial cancer.
Secondary
- Evaluate the partial and complete response rate after 3 months of treatment with everolimus in these patients.
- Evaluate the duration of response in these patients.
- Evaluate the clinical benefit after 6 months of treatment with everolimus in these patients.
- Evaluate the time to progression in these patients.
- Evaluate the progression-free and overall survival of these patients.
- Evaluate the nature, frequency, and severity of side effects of everolimus in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus daily in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly for 3 months and then every 3 months thereafter.
- Conditions
- Endometrial Cancer
- Being tested
- everolimus
- Keywords
- recurrent endometrial carcinoma, stage IV endometrial carcinoma, endometrial adenocarcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Drug: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Chauvenet, MD, Principal investigator, Hotel Dieu de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870337
- Sponsor's protocol ID
- CDR0000633321
- Other IDs
- ARCAGY-ENDORAD, NOVARTIS-ARCAGY-ENDORAD, ARCAGY-GINECO-EN101, INCA-RECF0512, EUDRACT-2007-003002-10
- Acronym
- ENDORAD
- Status last verified
- Oct 2014
- First submitted
- 26 Mar 2009
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ray-Coquard I, Favier L, Weber B, Roemer-Becuwe C, Bougnoux P, Fabbro M, Floquet A, Joly F, Plantade A, Paraiso D, Pujade-Lauraine E. Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO. Br J Cancer. 2013 May 14;108(9):1771-7. doi: 10.1038/bjc.2013.183. Epub 2013 Apr 23.
PubMed 23612453Tredan O, Treilleux I, Wang Q, Gane N, Pissaloux D, Bonnin N, Petit T, Cretin J, Bonichon-Lamichhane N, Priou F, Lavau-Denes S, Mari V, Freyer G, Lebrun D, Alexandre J, Ray-Coquard I. Predicting everolimus treatment efficacy in patients with advanced endometrial carcinoma: a GINECO group study. Target Oncol. 2013 Dec;8(4):243-51. doi: 10.1007/s11523-012-0242-9. Epub 2012 Dec 13.
PubMed 23238879
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer
- ClinicalTrials.gov ID
- NCT00870337
- Acronym / sponsor ID
- ENDORAD / CDR0000633321
- Conditions
- Endometrial Cancer
- Keywords
- recurrent endometrial carcinoma, stage IV endometrial carcinoma, endometrial adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2011 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer.
Detailed description
OBJECTIVES:
Primary
- Estimate the rate of non-progression after 3 months of treatment with everolimus in patients with relapsed or metastatic endometrial cancer.
Secondary
- Evaluate the partial and complete response rate after 3 months of treatment with everolimus in these patients.
- Evaluate the duration of response in these patients.
- Evaluate the clinical benefit after 6 months of treatment with everolimus in these patients.
- Evaluate the time to progression in these patients.
- Evaluate the progression-free and overall survival of these patients.
- Evaluate the nature, frequency, and severity of side effects of everolimus in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus daily in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly for 3 months and then every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: everolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| everolimus | Drug | Single arm |
Primary outcome
Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Derived from this study: PubMed 23612453Ray-Coquard I, Favier L, Weber B, Roemer-Becuwe C, Bougnoux P, Fabbro M, Floquet A, Joly F, Plantade A, Paraiso D, Pujade-Lauraine E. Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO. Br J Cancer. 2013 May 14;108(9):1771-7. doi: 10.1038/bjc.2013.183. Epub 2013 Apr 23.
- Derived from this study: PubMed 23238879Tredan O, Treilleux I, Wang Q, Gane N, Pissaloux D, Bonnin N, Petit T, Cretin J, Bonichon-Lamichhane N, Priou F, Lavau-Denes S, Mari V, Freyer G, Lebrun D, Alexandre J, Ray-Coquard I. Predicting everolimus treatment efficacy in patients with advanced endometrial carcinoma: a GINECO group study. Target Oncol. 2013 Dec;8(4):243-51. doi: 10.1007/s11523-012-0242-9. Epub 2012 Dec 13.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laure Chauvenet, MD principal investigator
Hotel Dieu de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing everolimus in people with Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870337, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.