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Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

A Phase 2 Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid or Islet Cell Cancer

NCT01010126•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.

Detailed Description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: I. To collect blood and tumor specimens from all patients entered on the trial for possible future analysis. OUTLINE: 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed endometrial (endometrioid, uterine, papillary serous carcinoma, and carcinosarcoma), ovarian (primary peritoneal/fallopian tube, serous, endometrioid, mixed, and poorly differentiated epithelial ovarian cancers \[for purposes of eligibility, carcinosarcoma is considered a poorly differentiated carcinoma\]), hepatocellular carcinoma, carcinoid or islet cell (neuroendocrine: well- or moderately-differentiated neuroendocrine) cancer which are locally advanced, recurrent, or metastatic
•Patients must have measurable disease; patients having only lesions measuring \>= 1 cm to \< 2 cm must use spiral computed tomography (CT) imaging for both pre- and post-treatment tumor assessments; patients who have had prior palliative radiotherapy to metastatic lesion(s) must have at least one measurable lesion(s) that have not been previously irradiated
•Radiation therapy (adjuvant or palliative) must be completed \>= 4 weeks prior to registration, if applicable
•Absolute neutrophil count (ANC) \>= 1500/mm\^3
•Platelets \>= 75,000/mm\^3
•Hemoglobin \>= 9.0 g/dL
•Total bilirubin =\< 1.5 x upper limit of normal (ULN); Note: direct bilirubin and international normalized ratio (INR) for hepatocellular carcinoma (HCC) patients allowed as per Child-Turcotte-Pugh scoring
•Alkaline phosphatase =\< 2.5 x ULN (=\< 5 x ULN if liver metastasis is present or patient is in HCC cohort)
•Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 x ULN (=\< 5 x ULN if liver metastasis is present or patient is in HCC cohort)
•Creatinine =\<1.5 x ULN
+46 more criteria

Exclusion Criteria

•Prior therapy with vascular endothelial growth factor receptor (VEGFR) targeting agents or mammalian target of rapamycin (mTOR) inhibitors (except as in HCC and in the Islet cell single agent bevacizumab alone cohort where prior mTOR inhibitor is allowed); Note: prior use of bevacizumab is not allowed in any cohort
•Invasive procedures defined as follows:
•* Major surgical procedure, open biopsy or significant traumatic injury =\< 4 weeks prior to registration
•* Anticipation of need for major surgical procedures during the course of the study
•* Core biopsy =\< 7 days prior to registration
•Serious or non-healing wound, ulcer or bone fracture
•History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =\< 180 days prior to first date of bevacizumab therapy
•Evidence of bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
•Evidence of a history bleeding =\< 6 months such as hemoptysis, or cerebrovascular accident =\< previous 6 months, or peripheral vascular disease with claudication on \< 1 block, or history of clinically significant bleeding, because of the potential bleeding and/or clotting risk with bevacizumab
•Untreated central nervous system (CNS) metastases; exceptions: patients with known CNS metastases can be enrolled if the brain metastases have been adequately treated and there is no evidence of progression or hemorrhage after treatment as ascertained by clinical examination and brain imaging (MRI or CT) =\< 12 weeks prior to registration and no ongoing requirement for steroids
+33 more criteria

Locations (61)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

University of Connecticut

Farmington, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Key Dates

Start Date

September 8, 2009

Primary Completion Date

March 13, 2017

Completion Date

March 13, 2017

Last Updated

January 25, 2019

Enrollment

252

ACTUAL participants

Conditions

Adult Hepatocellular CarcinomaAdvanced Adult Hepatocellular CarcinomaEndometrial Serous AdenocarcinomaLocalized Non-Resectable Adult Liver CarcinomaLung Carcinoid TumorMalignant Pancreatic GastrinomaMalignant Pancreatic GlucagonomaMalignant Pancreatic InsulinomaMalignant Pancreatic SomatostatinomaMetastatic Digestive System Neuroendocrine Tumor G1Ovarian CarcinosarcomaOvarian Endometrioid AdenocarcinomaOvarian Seromucinous CarcinomaOvarian Serous Surface Papillary AdenocarcinomaPancreatic Alpha Cell AdenomaPancreatic Beta Cell AdenomaPancreatic Delta Cell AdenomaPancreatic G-Cell AdenomaPancreatic Polypeptide TumorRecurrent Adult Liver CarcinomaRecurrent Digestive System Neuroendocrine Tumor G1Recurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Pancreatic Neuroendocrine CarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Uterine Corpus CarcinomaRegional Digestive System Neuroendocrine Tumor G1Stage IIIA Fallopian Tube CancerStage IIIA Ovarian CancerStage IIIA Primary Peritoneal CancerStage IIIA Uterine Corpus CancerStage IIIB Fallopian Tube CancerStage IIIB Ovarian CancerStage IIIB Primary Peritoneal CancerStage IIIB Uterine Corpus CancerStage IIIC Fallopian Tube CancerStage IIIC Ovarian CancerStage IIIC Primary Peritoneal CancerStage IIIC Uterine Corpus CancerStage IV Fallopian Tube CancerStage IV Ovarian CancerStage IV Primary Peritoneal CancerStage IVA Uterine Corpus CancerStage IVB Uterine Corpus CancerUterine Carcinosarcoma

Interventions

Bevacizumab

BIOLOGICAL

Temsirolimus

DRUG

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

NCT03660826

Endometrial AdenocarcinomaEndometrial Mixed Cell Adenocarcinoma+4 more

View study

ACTIVE_NOT_RECRUITINGPHASE2

Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

NCT05870761

Recurrent Endometrial Serous Adenocarcinoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 25, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

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