Trial · NCT01010126
Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
NCT01010126, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer. Trials, record NCT01010126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01010126
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
- NCT number
- NCT01010126
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 252 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, Endometrial Serous Adenocarcinoma, Localized Non-Resectable Adult Liver Carcinoma, Lung Carcinoid Tumor, Malignant Pancreatic Gastrinoma, Malignant Pancreatic Glucagonoma, Malignant Pancreatic Insulinoma, Malignant Pancreatic Somatostatinoma, Metastatic Digestive System Neuroendocrine Tumor G1, Ovarian Carcinosarcoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Surface Papillary Adenocarcinoma, Pancreatic Alpha Cell Adenoma, Pancreatic Beta Cell Adenoma, Pancreatic Delta Cell Adenoma, Pancreatic G-Cell Adenoma, Pancreatic Polypeptide Tumor, Recurrent Adult Liver Carcinoma, Recurrent Digestive System Neuroendocrine Tumor G1, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Pancreatic Neuroendocrine Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Uterine Corpus Carcinoma, Regional Digestive System Neuroendocrine Tumor G1, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIA Uterine Corpus Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IIIC Uterine Corpus Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer, Stage IVA Uterine Corpus Cancer, Stage IVB Uterine Corpus Cancer, Uterine Carcinosarcoma
- Interventions
- Bevacizumab, Temsirolimus
- First posted
- 2009-11-09
- Last updated
- 2019-01-25
- Results first posted
- 2019-01-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival Rate | 6 months | 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, or a measurable increase in a non-target lesion, or the appearance of new lesions. The 6-month progression free survival rate is the proportion of evaluable patients progression-free 6 months from registration. The 6-month progression-free rate is defined as the total number of efficacy evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of evaluable patients enrolled on study. Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval). |
| Primary | Tumor Response Rate | Up to 3 years | Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study. Patients were evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. In brief, a Complete Response (CR) means the complete disappearance of all target lesions and a reduction in each lymph node to \<1 cm. A Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of the non-nodal target lesion from baseline. Each requires no new lesions present at evaluation. The proportion of participants with a response is provided here for each cohort. The proportion was calculated as the number of patients that had a best response of CR or PR divided by the number of patients evaluated for a response in each cohort. |
| Secondary | Duration of Response | Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years | Duration of response is defined for all evaluable patients who have achieved a response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Objective response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) as described in Primary Objective 2 in this report. Median duration of response and the confidence interval for the median duration will be computed. |
| Secondary | Incidence of Adverse Events | Every cycle of treatment, up to 3 years | Adverse events are defined as events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0. The number of patients reporting grade 3 or higher adverse events at least possibly related to treatment are reported here. For a complete list of all reported adverse events, please see the adverse events section of this report. |
| Secondary | Overall Survival | Time from registration to death, assessed up to 3 years | Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. |
| Secondary | Time to Disease Progression | Time from registration to disease progression, assessed up to 3 years | Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for evaluation, that patient will be censored for progression of disease at day one post-registration. |
| Secondary | Time to Treatment Failure | Time from study entry to the date patients end treatment, assessed up to 3 years | Time to treatment failure is defined as the time from study entry to the date patients end treatment.Time to treatment failure will be evaluated using the method of Kaplan-Meier. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival Rate | 6 months | All patients that received study treatment and were evaluated for response are included in this analysis | proportion of patients | NUMBER |
| PRIMARY | Tumor Response Rate | Up to 3 years | For this analysis, the number of patients that had a best response of CR or PR were divided by the number of patients evaluated for a response. | proportion of participants | NUMBER |
| SECONDARY | Duration of Response | Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years | All patients that were assessed as a Complete Response or Partial Response were included in this analysis. | months | MEDIAN |
| SECONDARY | Incidence of Adverse Events | Every cycle of treatment, up to 3 years | All patients that received protocol treatment and were evaluated for adverse events are reported in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Time from registration to death, assessed up to 3 years | All patients that received study intervention and were followed for survival were included in this analysis. | months | MEDIAN |
| SECONDARY | Time to Disease Progression | Time from registration to disease progression, assessed up to 3 years | All patients that began protocol treatment and were evaluated for response are included in this analysis. | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | Time from study entry to the date patients end treatment, assessed up to 3 years | All patients that began study treatment were included in this analysis. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival Rate | Endometrial Cohort | 0.52 | 95% Confidence Interval 0.35 to 0.77 | proportion of patients | |
| Progression Free Survival Rate | Ovarian Cohort | 0.40 | 95% Confidence Interval 0.29 to 0.55 | proportion of patients | |
| Progression Free Survival Rate | Hepatocellular Cohort | 0.71 | 95% Confidence Interval 0.54 to 0.94 | proportion of patients | |
| Progression Free Survival Rate | Carcinoid Cohort | 0.84 | 95% Confidence Interval 0.75 to 0.95 | proportion of patients | |
| Progression Free Survival Rate | Islet Cell (Double Agent) Cohort | 0.85 | 95% Confidence Interval 0.75 to 0.95 | proportion of patients | |
| Progression Free Survival Rate | Islet Cell (Bevacizumab-only) Cohort | 0.87 | 95% Confidence Interval 0.74 to 1.00 | proportion of patients | |
| Tumor Response Rate | Endometrial Cohort | 0.31 | 95% Confidence Interval 0.14 to 0.52 | proportion of participants | |
| Tumor Response Rate | Ovarian Cohort | 0.31 | 95% Confidence Interval 0.20 to 0.45 | proportion of participants | |
| Tumor Response Rate | Hepatocellular Cohort | 0.19 | 95% Confidence Interval 0.06 to 0.38 | proportion of participants | |
| Tumor Response Rate | Carcinoid Cohort | 0.12 | 95% Confidence Interval 0.05 to 0.24 | proportion of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Endometrial Cohort | 27 | |
| Overall Study | STARTED | Ovarian Cohort | 58 | |
| Overall Study | STARTED | Hepatocellular Cohort | 28 | |
| Overall Study | STARTED | Carcinoid Cohort | 57 | |
| Overall Study | STARTED | Islet Cell (Double Agent) Cohort | 58 | |
| Overall Study | STARTED | Islet Cell (Bevacizumab-only) Cohort | 24 | |
| Overall Study | COMPLETED | Endometrial Cohort | 26 | |
| Overall Study | COMPLETED | Ovarian Cohort | 58 | |
| Overall Study | COMPLETED | Hepatocellular Cohort | 27 | |
| Overall Study | COMPLETED | Carcinoid Cohort | 57 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2,274
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 | Blood disorder | Blood and lymphatic system disorders | Endometrial Cohort | 0 | 26 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Ovarian Cohort | 1 | 58 | 1 |
| other | Blood disorder | Blood and lymphatic system disorders | Hepatocellular Cohort | 0 | 27 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Carcinoid Cohort | 1 | 57 | 2 |
| other | Blood disorder | Blood and lymphatic system disorders | Islet Cell (Double Agent) Cohort | 0 | 55 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Islet Cell (Bevacizumab-only) Cohort | 0 | 24 | 0 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Endometrial Cohort | 20 | 26 | 79 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Ovarian Cohort | 48 | 58 | 212 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Hepatocellular Cohort | 23 | 27 | 122 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Carcinoid Cohort | 49 | 57 | 382 |
1 to 10 of 2,274Source ClinicalTrials.gov
See all 2,274 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Endometrial Cohort | 2 | 26 |
| Total, all-cause mortality | Ovarian Cohort | 1 | 58 |
| Total, all-cause mortality | Hepatocellular Cohort | 3 | 27 |
| Total, all-cause mortality | Carcinoid Cohort | 3 | 57 |
| Total, all-cause mortality | Islet Cell (Double Agent) Cohort | 0 | 55 |
| Total, all-cause mortality | Islet Cell (Bevacizumab-only) Cohort | 0 | 24 |
| Total, other adverse events | Endometrial Cohort | 26 | 26 |
| Total, other adverse events | Ovarian Cohort | 58 | 58 |
| Total, other adverse events | Hepatocellular Cohort | 27 | 27 |
| Total, other adverse events | Carcinoid Cohort | 56 | 57 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| P50CA102701 | Mayo Clinic SPORE in Pancreatic Cancer | PETERSEN, GLORIA M.; BILLADEAU, DANIEL D | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 2004 to 2018 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01010126
GET https://conductscience.org/api/trials/v1/NCT01010126/results?page=2