AzTrials
AzTrials

Adult Hepatocellular CarcinomaPhase 2NCT01010126

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

A Phase 2 study testing Bevacizumab and Temsirolimus in people with Adult Hepatocellular Carcinoma and Advanced Adult Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 61 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab and Temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
61 sitesin 2 countries
Study dates
8 Sep 2009to 13 Mar 2017
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 56Show fewer
  • 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
  • Urinalysis < 2+ protein; urine protein should be screened by dipstick or urine analysis; for proteinuria >= 2+, 24-hour urine protein should be obtained and the level should be < 2 g for patient enrollment
  • Fasting serum cholesterol =< 350 mg/dL (=< 9.0 mmol/L)
  • Triglycerides =< 1.5 x ULN (mg/dL or mmol/L); patients with triglyceride levels > 1.5 x ULN can be started on lipid lowering agents and reevaluated within 1 week; if levels go to =< 1.5 x ULN, they can be considered for the trial and continue the lipid lowering agents; NOTE: cholesterol and triglyceride measurement and management are not required for single-agent bevacizumab cohort with islet cell carcinoma
  • International normalized ratio (INR) =< 1.5 (unless the patient is on full dose warfarin)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
  • Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; NOTE: patients and their partners should be practicing an effective form of contraception during the study and for at least 3 months following the last dose of this combined therapy
  • Full-dose anticoagulants, if a patient is receiving full-dose anticoagulants (except carcinoid tumors), the following criteria should be met for enrollment: the subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of low molecular weight (LMW) heparin
  • Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy; exception: in the case of endometrial cancer no prior chemotherapy for metastatic or recurrent disease is allowed; prior planned adjuvant chemotherapy is allowed
  • Patients who have had prior anthracycline must have a normal ejection fraction on left ventricular ejection fraction (LVEF) assessment by multigated acquisition scan (MUGA) or echocardiogram (Echo) =< 4 weeks prior to registration
  • Availability of tissue if applicable (from the primary tumor or metastases) for tumor studies for banking; Note: in the case of hepatocellular cancer if diagnosed by clinical and radiologic criteria only, availability of tissue not applicable
  • Willingness to donate blood for biomarker studies related to the type of therapies used in this trial and the tumor types being treated
  • ENDOMETRIAL CANCER (PERMANENTLY CLOSED TO ENROLLMENT)
  • Any hormonal therapy directed at the malignant tumor is allowed; NOTE: therapy must be discontinued at least one week prior to registration
  • Prior systemic therapy including biologic and immunologic agents as adjuvant treatment, must be discontinued at least 3 weeks prior to registration
  • Recurrent or persistent endometrial adenocarcinoma, uterine papillary serous carcinoma and carcinosarcoma which is refractory to curative therapy or established treatments; NOTE: histologic or cytologic confirmation of original primary tumor is required
  • HEPATOCELLULAR CANCER (PERMANENTLY CLOSED TO ENROLLMENT)
  • HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria; all of the following criteria must be met or a biopsy is required:
  • Known cirrhosis or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Hypervascular liver masses > 2 cm, and either serum alpha-fetoprotein (AFP) > 400 ng/ml, or
  • AFP > three times normal and doubling in value in the antecedent 3 months
  • Child-Pugh A (=< 6 points) or better liver status
  • Prior regional treatments for liver metastasis are permitted including:
  • Selective internal radiation therapy such as brachytherapy, cyberknife, radiolabeled microsphere embolization, etc.
  • Hepatic artery chemoembolization
  • Hepatic artery embolization
  • Hepatic artery infusional chemotherapy
  • Radiofrequency ablation NOTE: patients must be >= 4 weeks from treatment and show progressive disease in the liver after regional therapy or must have measurable disease outside the liver
  • Concomitant anti-viral therapy is allowed
  • History of prior varices or evidence of varices on pre-study CT/magnetic resonance imaging (MRI) imaging are required to undergo endoscopy =< 4 weeks prior to registration; those who had received specific therapy (banding and/or sclerotherapy) and had not bled within the prior 6 months are eligible
  • Suitably recovered from prior localized therapy, in the opinion of the investigator
  • ISLET CELL CANCER AND CARCINOID TUMOR (PERMANENTLY CLOSED TO ENROLLMENT)
  • Patient has evidence of progressive disease as documented by Response Evaluation Criteria in Solid Tumors (RECIST) =< 7 months prior to study entry
  • Carcinoid tumor cohort: prior and concurrent long-acting somatostatin analogue therapy is required; patient has to be on a stable dose of a long-acting somatostatin analogue >= 2 months prior to study entry with documentation of progressive disease on current dose
  • Islet cell tumor cohort: prior and/or concurrent long-acting somatostatin analogue therapy is allowed, but not required; if patient is continued on a long-acting somatostatin analogue, a stable dose for >= 2 months prior to study entry is required with documentation of progressive disease on current dose
  • Prior therapies allowed include:
  • =< 2 prior chemotherapy regimens
  • Prior interferon >= 4 weeks prior to registration
  • Radiolabeled octreotide therapy (patients with prior radiolabeled octreotide therapy should have progressive disease after such therapy)
  • Other investigational therapy NOTE: islet Cell Single Agent Bevacizumab Cohort: Prior mammalian target of rapamycin (mTOR) inhibitor is allowed
  • Prior regional treatments for liver metastasis are permitted including:
  • Selective internal radiation therapy such as brachytherapy, cyberknife, radiolabeled microsphere embolization, etc.
  • Hepatic artery chemoembolization
  • Hepatic artery embolization
  • Hepatic artery infusional chemotherapy
  • Radiofrequency ablation NOTE: patients must be >= 12 weeks from treatment and show progressive disease in the liver after regional therapy or must have measurable disease outside the liver

Who cannot join

  • 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
Show all 43Show fewer
  • 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
  • Anticonvulsants (stable dose) are allowed
  • Patients who had surgical resection of CNS metastases or brain biopsy =< 3 months prior to registration will be excluded
  • Significant cardiovascular disease defined as congestive heart failure (New York Heart Association class II, III or IV), angina pectoris requiring nitrate therapy, or recent myocardial infarction (=< 6 months prior to registration)
  • Uncontrolled hypertension (defined as a blood pressure of >= 150 mmHg systolic and/or >= 90 mmHg diastolic)
  • Patient is on angiotensin-converting-enzyme (ACE) inhibitors (benazapril, captopril, enalopril, fosonopril, lisinopril, moexipril, perindopril, quinopril, ramipril, and trandolapril); (patients may have an alternate antihypertensive substituted); NOTE: ACE inhibitors are allowed in single agent bevacizumab cohort
  • Currently active, second malignancy other than non-melanoma skin cancers; NOTE: patients are not considered to have a 'currently active' malignancy if they have completed anti-cancer therapy and are considered by their physician to be at less than 30% risk of relapse
  • Any of the following, as this regimen may be harmful to a developing fetus or nursing child:
  • Pregnant women
  • Breastfeeding women
  • Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) NOTE: the effects of the agent(s) on the developing human fetus at the recommended therapeutic dose are unknown
  • Known hypersensitivity to other recombinant human antibodies or Chinese hamster ovary cell products
  • Other uncontrolled serious medical or psychiatric condition (e.g. cardiac arrhythmias, diabetes, etc.)
  • Current therapy with a cytochrome P450 3A4 (CYP3A4) inhibitor or inducer; NOTE: these agents are allowed in the single-agent bevacizumab islet cell carcinoma cohort
  • Active infection requiring antibiotics
  • Active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)
  • Known human immunodeficiency virus (HIV)-positive
  • ENDOMETRIAL CANCER (PERAMANENTLY CLOSED TO ENROLLMENT)
  • Received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer
  • Any chemotherapy for metastatic or recurrent cancer
  • Radiation therapy to > 25% of marrow bearing areas
  • HEPATOCELLULAR CANCER EXCLUSION (PERMANENTLY CLOSED TO ENROLLMENT)
  • Child-Pugh B or C classification
  • Grade >= 3 hemorrhage =< 4 weeks prior to registration
  • Prior liver transplant with evidence of recurrent or metastatic disease
  • Patients on an active liver transplant list and considered likely to receive a liver transplant =< 6 months following registration
  • Clinical evidence of encephalopathy
  • Prior treatment with sorafenib or other vascular endothelial growth factor (VEGF) inhibitors; NOTE: Exceptions allowed for patients unable to tolerate the agent; intolerance is defined in this protocol as a discontinued agent due to side effects with an exposure < to 4 weeks of drug, at any dose level
  • OVARIAN CANCER (PERMANENTLY CLOSED TO ENROLLMENT)
  • Clinical signs and symptoms of gastrointestinal (GI) obstruction and require parental hydration/nutrition or tube feeding
  • Evidence of free abdominal air not explained by paracentesis or recent surgical procedures
  • Received more than two prior cytotoxic chemotherapy regimens for persistent or recurrent disease
  • CARCINOID (PERMANENTLY CLOSED TO ENROLLMENT)
  • Patients on anticoagulant therapy

Trial locations and contacts

61 sites in 2 countries.

61 sites in 2 countries

United States57 sites

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Cancer Care Center of Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • University of Connecticut

    Farmington, Connecticut, 06030

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Memorial Sloan Kettering Sleepy Hollow

    Sleepy Hollow, New York, 10591

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490

  • University of Maryland Saint Joseph Medical Center

    Towson, Maryland, 21204

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

Canada4 sites

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Bevacizumab, Temsirolimus
Medical subject headings
Carcinoma, Hepatocellular, Fallopian Tube Neoplasms, Ovarian Neoplasms, Somatostatinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Also called Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • TemsirolimusDrug

    Also called CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog

    Given IV

Study groups in NCT01010126
Study groupRoleWhat they receive
Treatment (temsirolimus, bevacizumab)ExperimentalPatients 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.
Receives: Biological: Bevacizumab; Drug: Temsirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival Rate

    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).

    Measured: 6 months

  2. Tumor Response Rate

    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.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Duration of Response

    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.

    Measured: 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

  2. Incidence of Adverse Events

    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.

    Measured: Every cycle of treatment, up to 3 years

  3. Overall Survival

    Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method.

    Measured: Time from registration to death, assessed up to 3 years

  4. Time to Disease Progression

    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.

    Measured: Time from registration to disease progression, assessed up to 3 years

  5. Time to Treatment Failure

    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.

    Measured: Time from study entry to the date patients end treatment, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2009 (estimated)
  2. Study start8 Sep 2009
  3. Primary completion13 Mar 2017
  4. Study completion13 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01010126
Sponsor's protocol ID
NCI-2012-02086
Other IDs
NCI-2012-02086, NCI-2011-02504, MC0845, CDR0000653790, NCI-2012-01049, 8233, 8233, N01CM00032
Status last verified
Jan 2019
First submitted
6 Nov 2009
Last updated
25 Jan 2019
Data monitoring committee
No

Publications

  • Abuzakhm SM, Sukrithan V, Fruth B, Qin R, Strosberg J, Hobday TJ, Semrad T, Reidy-Lagunes D, Kindler HL, Kim GP, Knox JJ, Kaubisch A, Villalona-Calero M, Chen H, Erlichman C, Shah MH. A phase II study of bevacizumab and temsirolimus in advanced extra-pancreatic neuroendocrine tumors. Endocr Relat Cancer. 2023 Sep 13;30(11):e220301. doi: 10.1530/ERC-22-0301. Print 2023 Nov 1.

    PubMed 37702588

  • Hobday TJ, Qin R, Reidy-Lagunes D, Moore MJ, Strosberg J, Kaubisch A, Shah M, Kindler HL, Lenz HJ, Chen H, Erlichman C. Multicenter Phase II Trial of Temsirolimus and Bevacizumab in Pancreatic Neuroendocrine Tumors. J Clin Oncol. 2015 May 10;33(14):1551-6. doi: 10.1200/JCO.2014.56.2082. Epub 2014 Dec 8.

    PubMed 25488966

  • Knox JJ, Qin R, Strosberg JR, Tan B, Kaubisch A, El-Khoueiry AB, Bekaii-Saab TS, Rousey SR, Chen HX, Erlichman C. A phase II trial of bevacizumab plus temsirolimus in patients with advanced hepatocellular carcinoma. Invest New Drugs. 2015 Feb;33(1):241-6. doi: 10.1007/s10637-014-0169-3. Epub 2014 Oct 16.

    PubMed 25318437

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in