Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
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|ClinicalTrials.gov Identifier: NCT01010126|
Recruitment Status : Completed
First Posted : November 9, 2009
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Biological: Bevacizumab Drug: Temsirolimus||Phase 2|
I. To determine the response rate and progression-free survival at 6 months in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer.
II. To determine the toxicity of the combination of temsirolimus and bevacizumab in patients with endometrial, ovarian, hepatocellular carcinoma, carcinoid or islet cell cancer.
I. To collect blood and tumor specimens from all patients entered on the trial for possible future analysis.
Patients receive temsirolimus intravenously (IV) on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||252 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid or Islet Cell Cancer|
|Study Start Date :||September 8, 2009|
|Actual Primary Completion Date :||March 13, 2017|
|Actual Study Completion Date :||March 13, 2017|
Experimental: Treatment (temsirolimus, bevacizumab)
Patients receive temsirolimus IV on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Progression Free Survival Rate [ Time Frame: 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).
- Tumor Response Rate [ Time Frame: 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.
- Duration of Response [ Time Frame: 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.
- Incidence of Adverse Events [ Time Frame: 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.
- Overall Survival [ Time Frame: 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.
- Time to Disease Progression [ Time Frame: 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.
- Time to Treatment Failure [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010126
|Principal Investigator:||Henry Pitot||Mayo Clinic|