Hormone Receptor Positive endometrIal Carcinoma Treated by Dual mTORC1/mTORC2 Inhibitor and Anastrozole (VICTORIA)
NCT ID: NCT02730923
Last Updated: 2024-02-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE1/PHASE2
Total Enrollment
72 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-04-30
Study Completion Date
2024-12-31
Brief Summary
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The investigators hypothesize that the dual inhibition of mTORC1/mTORC2 by AZD2014 combined with inhibition of aromatase enzyme by anastrozole will act synergistically and may be an interesting therapeutic option for endometrial cancer with a manageable toxicity profile.
The investigators proposal is to conduct a multicenter, 2-step, randomized, Phase I/II trial to evaluate the safety and efficacy of a combination treatment associating anastrozole to AZD2014 in advanced endometrial cancer patients.
The study is divided in 2 steps :
* A safety run-in phase aiming to evaluate the safety of the proposed combination AZD2014 + anastrozole (Arm A) versus anastrozole alone (Arm B). No dose escalation is scheduled (doses are based on maximum tolerated dose (MTD) defined for AZD2014 and the summary of product characteristics (SPC) of anastrozole). However, dose de-escalation for AZD2014 will be applied in case of toxicity.
* A two-stage randomized Phase II part aiming to evaluate the clinical benefit of the AZD2014 + anastrozole (Arm A) combination therapy versus anastrozole (Arm B).
The investigators proposal is to conduct a multicenter, 2-step, randomized, Phase I/II trial to evaluate the safety and efficacy of a combination treatment associating anastrozole to AZD2014 in advanced endometrial cancer patients.
The study is divided in 2 steps :
* A safety run-in phase aiming to evaluate the safety of the proposed combination AZD2014 + anastrozole (Arm A) versus anastrozole alone (Arm B). No dose escalation is scheduled (doses are based on maximum tolerated dose (MTD) defined for AZD2014 and the summary of product characteristics (SPC) of anastrozole). However, dose de-escalation for AZD2014 will be applied in case of toxicity.
* A two-stage randomized Phase II part aiming to evaluate the clinical benefit of the AZD2014 + anastrozole (Arm A) combination therapy versus anastrozole (Arm B).
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Detailed Description
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TREATMENT PLAN :
Following randomisation patients will receive Arm A : AZD2014 plus anastrozole or Arm B: anastrozole alone AZD2014 will be administered with an intermittent schedule i.e. 125 mg bis in die (BID) intermittent with 2 days on followed by 5 days off per week for a total weekly dose of 500 mg/week (250mg D1 and D2, 5 days off) Anastrozole will be administered at the standard dose defined in the SPC i.e. 1mg/d, per os, continuously.
Both treatment will be administered until progressive disease (PD), unacceptable toxicity or willingness to stop.
STATISTICS :
A total of 72 patients will be randomized in the study.
Safety run-in Phase on the first 9 patients randomized - As no dose escalation will be performed, the safety will be evaluated following the treatment and 8-week follow-up of the first 6 patients by the experimental association AZD2014+anastrozole (experimental arm). By similarity to a classic 3+3 design, based on binomial probabilities, there is a 90% probability of observing one or more patients with a toxicity event, if that event occurs in at least 32% of the target population. Assuming a 2:1 randomization ratio, a total of 9 patients (Arm A - Experimental: 6 patients, Arm B - Control: 3 patients) will be enrolled in this safety run-in phase and will be included in the evaluation of Phase II part.
Phase II The sample size calculation was based on a Simon optimal two-stage design, with a minimum success (8-week non progression) rate considered of interest p1=60% and an uninteresting rate p0=40%. Assuming a type I error alpha of 0.05 and 80% power, 46 evaluable patients are needed in the experimental arm to reject the null hypothesis H0: p≤p0 versus the alternative hypothesis H1: p ≥ p1 in a unilateral situation (16 patients in Stage I and 30 additional patients in Stage II).
With a 2:1 randomization and based on the assumption that 5% of the patients may be non-evaluable, a total of 72 patients will be included in the study : 48 patients in Arm A - experimental and 24 patients in Arm B - control).
DATA ENTRY, DATA MANAGEMENT AND STUDY MONITORING All the data concerning the patients will be recorded in the electronic case report form (eCRF) throughout the study. serious adverse event (SAE) reporting will be also paper-based by e-mail and/or Fax.
The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol, Good Clinical Practices (GCP) and local law requirements.
Following randomisation patients will receive Arm A : AZD2014 plus anastrozole or Arm B: anastrozole alone AZD2014 will be administered with an intermittent schedule i.e. 125 mg bis in die (BID) intermittent with 2 days on followed by 5 days off per week for a total weekly dose of 500 mg/week (250mg D1 and D2, 5 days off) Anastrozole will be administered at the standard dose defined in the SPC i.e. 1mg/d, per os, continuously.
Both treatment will be administered until progressive disease (PD), unacceptable toxicity or willingness to stop.
STATISTICS :
A total of 72 patients will be randomized in the study.
Safety run-in Phase on the first 9 patients randomized - As no dose escalation will be performed, the safety will be evaluated following the treatment and 8-week follow-up of the first 6 patients by the experimental association AZD2014+anastrozole (experimental arm). By similarity to a classic 3+3 design, based on binomial probabilities, there is a 90% probability of observing one or more patients with a toxicity event, if that event occurs in at least 32% of the target population. Assuming a 2:1 randomization ratio, a total of 9 patients (Arm A - Experimental: 6 patients, Arm B - Control: 3 patients) will be enrolled in this safety run-in phase and will be included in the evaluation of Phase II part.
Phase II The sample size calculation was based on a Simon optimal two-stage design, with a minimum success (8-week non progression) rate considered of interest p1=60% and an uninteresting rate p0=40%. Assuming a type I error alpha of 0.05 and 80% power, 46 evaluable patients are needed in the experimental arm to reject the null hypothesis H0: p≤p0 versus the alternative hypothesis H1: p ≥ p1 in a unilateral situation (16 patients in Stage I and 30 additional patients in Stage II).
With a 2:1 randomization and based on the assumption that 5% of the patients may be non-evaluable, a total of 72 patients will be included in the study : 48 patients in Arm A - experimental and 24 patients in Arm B - control).
DATA ENTRY, DATA MANAGEMENT AND STUDY MONITORING All the data concerning the patients will be recorded in the electronic case report form (eCRF) throughout the study. serious adverse event (SAE) reporting will be also paper-based by e-mail and/or Fax.
The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol, Good Clinical Practices (GCP) and local law requirements.
Conditions
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Endometrial Carcinoma
Metastatic Carcinoma
Hormone Receptor Positive Tumor
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm A: AZD2014 plus anastrozole
Group Type
EXPERIMENTAL
AZD2014
Intervention Type
DRUG
Following inclusion, patients will be randomized (2:1) to receive Arm A : AZD2014 + anastrozole Arm B : anastrozole alone
Mode of Action Selective and specific mTOR kinase inhibitor targeting both mTORC1 and mTORC2 complexes.
Route of Administration Oral
Dosage regimen 125mg BID with intermittent schedule (2 days of treatment followed by 5 days off (500mg/week))
Duration of treatment Until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request.
Anastrozole
Intervention Type
DRUG
Therapeutic Class Aromatase inhibitor
Mode of Action Potent and highly selective non-steroidal aromatase inhibitor.
Route of Administration Oral
Dosage regimen
1 mg tablet once a day
Duration of treatment Patients may continue treatment with anastrozole until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request.
Arm B: anastrozole alone
Group Type
ACTIVE_COMPARATOR
Anastrozole
Intervention Type
DRUG
Therapeutic Class Aromatase inhibitor
Mode of Action Potent and highly selective non-steroidal aromatase inhibitor.
Route of Administration Oral
Dosage regimen
1 mg tablet once a day
Duration of treatment Patients may continue treatment with anastrozole until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request.
Interventions
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AZD2014
Following inclusion, patients will be randomized (2:1) to receive Arm A : AZD2014 + anastrozole Arm B : anastrozole alone
Mode of Action Selective and specific mTOR kinase inhibitor targeting both mTORC1 and mTORC2 complexes.
Route of Administration Oral
Dosage regimen 125mg BID with intermittent schedule (2 days of treatment followed by 5 days off (500mg/week))
Duration of treatment Until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request.
Intervention Type
DRUG
Anastrozole
Therapeutic Class Aromatase inhibitor
Mode of Action Potent and highly selective non-steroidal aromatase inhibitor.
Route of Administration Oral
Dosage regimen
1 mg tablet once a day
Duration of treatment Patients may continue treatment with anastrozole until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request.
Intervention Type
DRUG
Other Intervention Names
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Arimidex
Eligibility Criteria
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Inclusion Criteria
* Postmenopausal female patient at the time of consent
* Histologically-confirmed diagnosis of advanced or recurrent endometrial carcinoma, not amenable to curative treatments. Carcinosarcoma are not eligible.
* Documented estrogen receptor and/or progesterone receptor positive endometrial cancer. Hormone receptor positivity is defined according to routine practice at each participating site.
* Availability of a pre-treatment tumor sample (archival formalin-fixed paraffin-embedded (FFPE) block or fresh biopsy if feasible) and presence of at least one biopsiable tumor lesion for on-treatment biopsy
* Documented disease progression after no more than one prior first-line chemotherapy regimen and/or more than 2 lines endocrine therapy in the metastatic setting
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 and minimum life expectancy of 8 weeks
* At least one measurable lesion according to response evaluation criteria in solid tumor (RECIST 1.1)
* Adequate bone marrow, renal and liver function as shown by:
* Absolute neutrophil count \> 1.5 x 109/L, Platelets \> 100 x 109/L, Hemoglobin (Hb) \>9 g/dL
* Serum bilirubin ≤ 1.5 upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase ≤ 2.5 ULN (≤ 5 ULN in patients with liver metastases)
* Creatinine clearance \> 50 mL/min (using Cockcroft formula, or MDRD formula for patients over 65 years Appendix 3 - Creatinine Clearance)
* Fasting serum cholesterol ≤ 300 mg/dL (7.75 mmol/L) AND fasting triglycerides ≤ 2.5 ULN (lipid-lowering drugs allowed),
* Fasting plasma glucose ≤7 mmol/L (126 mg/dL)
* Recovered from prior significant treatment-related toxicity i.e. no persistent treatment-related toxicity \> Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) v4.3, except grade 2 alopecia, grade 2 anemia but with Hb \>9 g/dL.
* Minimal wash-out period before the start of the study drugs for the following treatments:
* Any anti-cancer treatment approved or investigational medicinal product :\> 21 days
* Any chemotherapy, radiation therapy, androgens : \> 21 days (not including palliative radiotherapy at focal sites).
* Any monoclonal antibody therapy: \> 4 weeks
* Major surgery: \> 4 weeks
* Minor surgery (excluding tumour biopsies) \>14 days.
* Any haemopoietic growth factors (e.g., filgrastim \[granulocyte colony-stimulating factor (G-CSF)\], sargramostim \[granulocyte-macrophage colony-stimulating factor (GM-CSF)\]): \> 14 days
* Vaccinated with live, attenuated vaccines : \> 4 weeks.
* Sensitive or narrow therapeutic range substrates of drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K: see the appropriate wash-out period (a minimum of 5 x reported elimination half-life) in Appendix 5 - Restricted CYP and transporter related co-medications
* Potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP - Restricted CYP and transporter related co-medications
* Patient willing to follow sunlight-protection measures. Patients should be advised of the need for sunlight protection measures during administration of AZD2014, and should be advised to adopt such measures for a period of 3 months after receiving their final dose of AZD2014.
* Patient able and willing to provide informed consent with ability to understand and willingness for follow-up visits.
* Covered by a medical insurance
* Histologically-confirmed diagnosis of advanced or recurrent endometrial carcinoma, not amenable to curative treatments. Carcinosarcoma are not eligible.
* Documented estrogen receptor and/or progesterone receptor positive endometrial cancer. Hormone receptor positivity is defined according to routine practice at each participating site.
* Availability of a pre-treatment tumor sample (archival formalin-fixed paraffin-embedded (FFPE) block or fresh biopsy if feasible) and presence of at least one biopsiable tumor lesion for on-treatment biopsy
* Documented disease progression after no more than one prior first-line chemotherapy regimen and/or more than 2 lines endocrine therapy in the metastatic setting
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 and minimum life expectancy of 8 weeks
* At least one measurable lesion according to response evaluation criteria in solid tumor (RECIST 1.1)
* Adequate bone marrow, renal and liver function as shown by:
* Absolute neutrophil count \> 1.5 x 109/L, Platelets \> 100 x 109/L, Hemoglobin (Hb) \>9 g/dL
* Serum bilirubin ≤ 1.5 upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase ≤ 2.5 ULN (≤ 5 ULN in patients with liver metastases)
* Creatinine clearance \> 50 mL/min (using Cockcroft formula, or MDRD formula for patients over 65 years Appendix 3 - Creatinine Clearance)
* Fasting serum cholesterol ≤ 300 mg/dL (7.75 mmol/L) AND fasting triglycerides ≤ 2.5 ULN (lipid-lowering drugs allowed),
* Fasting plasma glucose ≤7 mmol/L (126 mg/dL)
* Recovered from prior significant treatment-related toxicity i.e. no persistent treatment-related toxicity \> Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) v4.3, except grade 2 alopecia, grade 2 anemia but with Hb \>9 g/dL.
* Minimal wash-out period before the start of the study drugs for the following treatments:
* Any anti-cancer treatment approved or investigational medicinal product :\> 21 days
* Any chemotherapy, radiation therapy, androgens : \> 21 days (not including palliative radiotherapy at focal sites).
* Any monoclonal antibody therapy: \> 4 weeks
* Major surgery: \> 4 weeks
* Minor surgery (excluding tumour biopsies) \>14 days.
* Any haemopoietic growth factors (e.g., filgrastim \[granulocyte colony-stimulating factor (G-CSF)\], sargramostim \[granulocyte-macrophage colony-stimulating factor (GM-CSF)\]): \> 14 days
* Vaccinated with live, attenuated vaccines : \> 4 weeks.
* Sensitive or narrow therapeutic range substrates of drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K: see the appropriate wash-out period (a minimum of 5 x reported elimination half-life) in Appendix 5 - Restricted CYP and transporter related co-medications
* Potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP - Restricted CYP and transporter related co-medications
* Patient willing to follow sunlight-protection measures. Patients should be advised of the need for sunlight protection measures during administration of AZD2014, and should be advised to adopt such measures for a period of 3 months after receiving their final dose of AZD2014.
* Patient able and willing to provide informed consent with ability to understand and willingness for follow-up visits.
* Covered by a medical insurance
Exclusion Criteria
* Patient pre-treated by a non-steroidal aromatase inhibitor
* Active uncontrolled or symptomatic central nervous system metastases or spinal cord compression
* Clinically relevant abnormal levels of potassium or sodium.
* Use of any forbidden concomitant treatment during the treatment period:
* Any anti-cancer treatment (approved or investigational) not mentioned in the protocol
* Chronic treatment with corticosteroids or other immunosuppressive agents. Stable low dose of corticosteroids are allowed (unless contra-indicated) provided that they were initiated before the last disease progression or were started at least 4 weeks prior to study treatment. Topical or inhaled corticosteroids are allowed.
* Potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP (see Appendix 5 - Restricted CYP and transporter related co-medications)
* Sensitive or narrow therapeutic range substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K outside the wash out period and restrictions presented in Appendix 5 - Restricted CYP and transporter related co-medications)
* Patient with known hypersensitivity to anastrozole or to any of the excipients (Lactose monohydrate, Povidone, Sodium starch glycollate, Magnesium stearate, Hypromellose, Macrogol 300, Titanium dioxide)
* History of hypersensitivity to active or inactive excipients of AZD2014 or drugs with a similar chemical structure or class to AZD2014
* History of other malignancies except for basal cell or squamous cell skin cancer, in situ cervical cancer, unless they have been disease-free for at least five years
* Patient who has any severe and/or uncontrolled medical conditions such as:
* Recent history of specific cardiovascular events, or laboratory parameters that may affect cardiac parameters including : unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to start of study drug, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease; Symptomatic congestive heart failure of New York heart Association Class III or IV
* Haemorrhagic or thrombotic stroke, including transient ischemic attack (TIA) or any other CNS bleeding.
* Mean resting corrected QT interval (QTc), calculated using Fridericia's formula, \> 470 msec obtained from 3 electrocardiograms (ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months of the patient entering in the study
* Abnormal cardiac function at baseline :left ventricular ejection fraction (LVEF) \<50%
* Any evidence of interstitial lung disease and uncompensated respiratory conditions.
* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active or chronic hepatitis (i.e. quantifiable hepatitis B virus (HBV-DNA) and/or positive HbsAg, quantifiable hepatitis C virus (HCV-RNA)),
* Active, bleeding diathesis
* Current refractory nausea and vomiting, chronic gastro-intestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD2014.
* Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
* Type 1 and uncontrolled Type 2 diabetes
* Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis.
* Active uncontrolled or symptomatic central nervous system metastases or spinal cord compression
* Clinically relevant abnormal levels of potassium or sodium.
* Use of any forbidden concomitant treatment during the treatment period:
* Any anti-cancer treatment (approved or investigational) not mentioned in the protocol
* Chronic treatment with corticosteroids or other immunosuppressive agents. Stable low dose of corticosteroids are allowed (unless contra-indicated) provided that they were initiated before the last disease progression or were started at least 4 weeks prior to study treatment. Topical or inhaled corticosteroids are allowed.
* Potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP (see Appendix 5 - Restricted CYP and transporter related co-medications)
* Sensitive or narrow therapeutic range substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K outside the wash out period and restrictions presented in Appendix 5 - Restricted CYP and transporter related co-medications)
* Patient with known hypersensitivity to anastrozole or to any of the excipients (Lactose monohydrate, Povidone, Sodium starch glycollate, Magnesium stearate, Hypromellose, Macrogol 300, Titanium dioxide)
* History of hypersensitivity to active or inactive excipients of AZD2014 or drugs with a similar chemical structure or class to AZD2014
* History of other malignancies except for basal cell or squamous cell skin cancer, in situ cervical cancer, unless they have been disease-free for at least five years
* Patient who has any severe and/or uncontrolled medical conditions such as:
* Recent history of specific cardiovascular events, or laboratory parameters that may affect cardiac parameters including : unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to start of study drug, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease; Symptomatic congestive heart failure of New York heart Association Class III or IV
* Haemorrhagic or thrombotic stroke, including transient ischemic attack (TIA) or any other CNS bleeding.
* Mean resting corrected QT interval (QTc), calculated using Fridericia's formula, \> 470 msec obtained from 3 electrocardiograms (ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months of the patient entering in the study
* Abnormal cardiac function at baseline :left ventricular ejection fraction (LVEF) \<50%
* Any evidence of interstitial lung disease and uncompensated respiratory conditions.
* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active or chronic hepatitis (i.e. quantifiable hepatitis B virus (HBV-DNA) and/or positive HbsAg, quantifiable hepatitis C virus (HCV-RNA)),
* Active, bleeding diathesis
* Current refractory nausea and vomiting, chronic gastro-intestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD2014.
* Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
* Type 1 and uncontrolled Type 2 diabetes
* Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Centre Leon Berard
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Pierre-Etienne HEUDEL, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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ICO - Paul Papin
Angers, , France
Site Status
Institut Sainte Catherine
Avignon, , France
Site Status
Hôpital Jean Minjoz
Besançon, , France
Site Status
Institut Bergonié
Bordeaux, , France
Site Status
Centre Francois Baclesse
Caen, , France
Site Status
GHM Institut Daniel Hollard
Grenoble, , France
Site Status
Centre Oscar Lambret
Lille, , France
Site Status
Centre Léon Bérard
Lyon, , France
Site Status
Institut régional du Cancer Montpellier (ICM)
Montpellier, , France
Site Status
Hcl - Chls
Pierre-Bénite, , France
Site Status
ICO - René Gauducheau
Saint-Herblain, , France
Site Status
Institut Gustave Roussy
Villejuif, , France
Site Status
Countries
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France
References
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Levine DA, Hoskins WJ. Update in the management of endometrial cancer. Cancer J. 2002 May-Jun;8 Suppl 1:S31-40.
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Murali R, Soslow RA, Weigelt B. Classification of endometrial carcinoma: more than two types. Lancet Oncol. 2014 Jun;15(7):e268-78. doi: 10.1016/S1470-2045(13)70591-6.
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BACKGROUND
Creasman WT, Odicino F, Maisonneuve P, Quinn MA, Beller U, Benedet JL, Heintz AP, Ngan HY, Pecorelli S. Carcinoma of the corpus uteri. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer. Int J Gynaecol Obstet. 2006 Nov;95 Suppl 1:S105-43. doi: 10.1016/S0020-7292(06)60031-3. No abstract available.
Reference Type
BACKGROUND
Sonoda Y. Optimal therapy and management of endometrial cancer. Expert Rev Anticancer Ther. 2003 Feb;3(1):37-47. doi: 10.1586/14737140.3.1.37.
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Decruze SB, Green JA. Hormone therapy in advanced and recurrent endometrial cancer: a systematic review. Int J Gynecol Cancer. 2007 Sep-Oct;17(5):964-78. doi: 10.1111/j.1525-1438.2007.00897.x. Epub 2007 Apr 18.
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BACKGROUND
Kokka F, Brockbank E, Oram D, Gallagher C, Bryant A. Hormonal therapy in advanced or recurrent endometrial cancer. Cochrane Database Syst Rev. 2010 Dec 8;2010(12):CD007926. doi: 10.1002/14651858.CD007926.pub2.
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BACKGROUND
Rose PG, Brunetto VL, VanLe L, Bell J, Walker JL, Lee RB. A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2000 Aug;78(2):212-6. doi: 10.1006/gyno.2000.5865.
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Diaz-Padilla I, Duran I, Clarke BA, Oza AM. Biologic rationale and clinical activity of mTOR inhibitors in gynecological cancer. Cancer Treat Rev. 2012 Oct;38(6):767-75. doi: 10.1016/j.ctrv.2012.02.001. Epub 2012 Feb 29.
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BACKGROUND
Slomovitz BM, Coleman RL. The PI3K/AKT/mTOR pathway as a therapeutic target in endometrial cancer. Clin Cancer Res. 2012 Nov 1;18(21):5856-64. doi: 10.1158/1078-0432.CCR-12-0662. Epub 2012 Oct 18.
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BACKGROUND
Oza AM, Elit L, Tsao MS, Kamel-Reid S, Biagi J, Provencher DM, Gotlieb WH, Hoskins PJ, Ghatage P, Tonkin KS, Mackay HJ, Mazurka J, Sederias J, Ivy P, Dancey JE, Eisenhauer EA. Phase II study of temsirolimus in women with recurrent or metastatic endometrial cancer: a trial of the NCIC Clinical Trials Group. J Clin Oncol. 2011 Aug 20;29(24):3278-85. doi: 10.1200/JCO.2010.34.1578. Epub 2011 Jul 25.
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BACKGROUND
Slomovitz BM, Jiang Y, Yates MS, Soliman PT, Johnston T, Nowakowski M, Levenback C, Zhang Q, Ring K, Munsell MF, Gershenson DM, Lu KH, Coleman RL. Phase II study of everolimus and letrozole in patients with recurrent endometrial carcinoma. J Clin Oncol. 2015 Mar 10;33(8):930-6. doi: 10.1200/JCO.2014.58.3401. Epub 2015 Jan 26.
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BACKGROUND
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
Reference Type
BACKGROUND
Trimble EL, Harlan LC, Clegg LX, Stevens JL. Pre-operative imaging, surgery and adjuvant therapy for women diagnosed with cancer of the corpus uteri in community practice in the United States. Gynecol Oncol. 2005 Mar;96(3):741-8. doi: 10.1016/j.ygyno.2004.11.041.
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DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_v40.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VICTORIA (ET150036)
Identifier Type: -
Identifier Source: org_study_id
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