Trial · NCT00729586
Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer
NCT00729586, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2018-08-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer. Trials, record NCT00729586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00729586
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer
- NCT number
- NCT00729586
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 73 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Endometrial Carcinoma, Recurrent Uterine Corpus Carcinoma, Stage IIIA Uterine Corpus Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC1 Uterine Corpus Cancer, Stage IIIC2 Uterine Corpus Cancer, Stage IVA Uterine Corpus Cancer, Stage IVB Uterine Corpus Cancer
- Interventions
- Laboratory Biomarker Analysis, Megestrol Acetate, Tamoxifen Citrate, Temsirolimus
- First posted
- 2008-08-07
- Last updated
- 2019-07-23
- Results first posted
- 2018-08-27
- Limitations and caveats
- The combination arm was closed after the first stage of accrual due to an excess of venous thromboses.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Confirmed Objective Tumor Response Using RECIST Version 1.0 | Radiologic tumor evaluations at baseline and every 6 weeks for the first 24 weeks; then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression. | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. |
| Secondary | Duration of Overall Survival (OS) | Every 6 weeks during treatment, then every 3 months for one year. | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. |
| Secondary | Duration of Progression-free Survival (PFS) | Radiologic tumor evaluations at baseline and every six weeks for the first 24 weeks and then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression. | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions. |
| Secondary | Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment. | Number of participants with a maximum grade of 3 or higher during the treatment period. |
| Other | Number of Participants and Their Levels of Expression of the Candidate Markers | Baseline | The levels of expression of the candidate markers measured prior to study treatment are tabulated. The expressions being tabulated include immunohistochemical expression of hormone receptors. The hormone receptors are estrogen receptor positive, progesterone receptors-A, progesterone receptor-B, PAKT Positive and PTEN Positive. The associations between the immunohistochemical expression of these biomarkers and between these biomarkers and treatment, outcome or clinical characteristics are reported for future investigation. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Confirmed Objective Tumor Response Using RECIST Version 1.0 | Radiologic tumor evaluations at baseline and every 6 weeks for the first 24 weeks; then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression. | Eligible and treated patients | percentage of participants | NUMBER |
| SECONDARY | Duration of Overall Survival (OS) | Every 6 weeks during treatment, then every 3 months for one year. | Eligible and treated patients | months | MEDIAN |
| SECONDARY | Duration of Progression-free Survival (PFS) | Radiologic tumor evaluations at baseline and every six weeks for the first 24 weeks and then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression. | Eligible and treated patients | months | MEDIAN |
| SECONDARY | Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment. | Eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants and Their Levels of Expression of the Candidate Markers | Baseline | Eligible and treated patients with primary tumor specimen | participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Confirmed Objective Tumor Response Using RECIST Version 1.0 | Arm 1: Temsirolimus | 22 | 94% Confidence Interval 11 to 52 | percentage of participants | |
| Percentage of Participants With a Confirmed Objective Tumor Response Using RECIST Version 1.0 | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 14.3 | 94% Confidence Interval 3 to 36 | percentage of participants | |
| Duration of Overall Survival (OS) | Arm 1: Temsirolimus | 13.3 | 95% Confidence Interval 9.8 to 20.7 | months | |
| Duration of Overall Survival (OS) | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 9.6 | 95% Confidence Interval 6.4 to 16.3 | months | |
| Duration of Progression-free Survival (PFS) | Arm 1: Temsirolimus | 5.6 | 95% Confidence Interval 4.0 to 8.2 | months | |
| Duration of Progression-free Survival (PFS) | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 4.2 | 95% Confidence Interval 1.5 to 6.2 | months | |
| Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Arm 1: Temsirolimus | 29 | Participants | ||
| Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 15 | Participants | ||
| Number of Participants and Their Levels of Expression of the Candidate Markers | Receptor Analysis | Estrogen Receptor Positive | 20 | participants | |
| Number of Participants and Their Levels of Expression of the Candidate Markers | Receptor Analysis | Progesterone Receptor Positive | 30 | participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Temsirolimus | 51 | |
| Overall Study | STARTED | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 22 | |
| Overall Study | COMPLETED | Arm 1: Temsirolimus | 50 | |
| Overall Study | COMPLETED | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 21 | |
| Overall Study | NOT COMPLETED | Arm 1: Temsirolimus | 1 | |
| Overall Study | NOT COMPLETED | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 1 |
Source ClinicalTrials.gov
Adverse events428
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm 1: Temsirolimus | 1 | 50 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 1 | 21 | |
| other | Rhinitis | Immune system disorders | Arm 1: Temsirolimus | 2 | 50 | |
| other | Rhinitis | Immune system disorders | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 3 | 21 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Arm 1: Temsirolimus | 0 | 50 | |
| other | Auditory/Ear - Other | Ear and labyrinth disorders | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 1 | 21 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm 1: Temsirolimus | 1 | 50 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 0 | 21 | |
| other | Neutrophils | Blood and lymphatic system disorders | Arm 1: Temsirolimus | 15 | 50 | |
| other | Neutrophils | Blood and lymphatic system disorders | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 4 | 21 |
1 to 10 of 428Source ClinicalTrials.gov
See all 428 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Temsirolimus | 33 | 50 |
| Total, all-cause mortality | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 16 | 21 |
| Total, other adverse events | Arm 1: Temsirolimus | 50 | 50 |
| Total, other adverse events | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 21 | 21 |
| Total, serious adverse events | Arm 1: Temsirolimus | 18 | 50 |
| Total, serious adverse events | Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus | 13 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1: Temsirolimus vs Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus: Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Trial comparisons |
| Arm 1: Temsirolimus vs Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus: deaths from any cause | Trial comparisons |
| Arm 1: Temsirolimus vs Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00729586
GET https://conductscience.org/api/trials/v1/NCT00729586/events?page=2