Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Adult Hepatocellular Carcinoma
Advanced Adult Hepatocellular Carcinoma
Endometrial Serous Adenocarcinoma
Localized Non-Resectable Adult Liver Carcinoma
Lung Carcinoid Tumor
Malignant Ovarian Mixed Epithelial Tumor
Malignant Pancreatic Gastrinoma
Malignant Pancreatic Glucagonoma
Malignant Pancreatic Insulinoma
Malignant Pancreatic Somatostatinoma
Metastatic Digestive System Neuroendocrine Tumor G1
Ovarian Endometrioid Adenocarcinoma
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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid or Islet Cell Cancer|
- Progression free survival rate, defined as the proportion of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration [ Time Frame: 6 months ] [ Designated as safety issue: No ]A 95% confidence interval for the true response rate will be constructed using the Duffy-Santner approach. However, Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval) if there are censored patients.
- 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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]A 95% confidence interval for the true response rate will be constructed using the Duffy-Santner approach.
- 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 ] [ Designated as safety issue: No ]Median duration of response and the confidence interval for the median duration will be computed.
- Incidence of adverse events, defined as adverse 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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
- Overall survival [ Time Frame: Time from registration to death, assessed up to 3 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Time from study entry to the date patients end treatment, assessed up to 3 years ] [ Designated as safety issue: No ]Time to treatment failure will be evaluated using the method of Kaplan-Meier.
|Study Start Date:||September 2009|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010126
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|Principal Investigator:||Charles Erlichman||Mayo Clinic Cancer Center P2C|