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

January 24, 2019 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Mississauga, Ontario, Canada, L5M 2N1
        • Trillium Health Partners - Credit Valley Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • California
      • Beverly Hills, California, United States, 90211-1850
        • Tower Cancer Research Foundation
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Los Angeles County-USC Medical Center
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • South Pasadena, California, United States, 91030
        • City of Hope South Pasadena
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University/Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Center of Decatur
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Springfield, Illinois, United States, 62781
        • Memorial Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Maryland
      • Towson, Maryland, United States, 21204
        • University of Maryland Saint Joseph Medical Center
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
    • New York
      • Bronx, New York, United States, 10467-2490
        • Montefiore Medical Center - Moses Campus
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Sleepy Hollow, New York, United States, 10591
        • Memorial Sloan Kettering Sleepy Hollow
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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

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

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Bevacizumab
Given IV
Other Names:
  • Avastin
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF rhuMAb
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar FKB238
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
Drug: Temsirolimus
Given IV
Other Names:
  • Torisel
  • CCI-779
  • CCI-779 Rapamycin Analog
  • Cell Cycle Inhibitor 779
  • Rapamycin Analog
  • Rapamycin Analog CCI-779

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months
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.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Every cycle of treatment, up to 3 years
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 from registration to death, assessed up to 3 years
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 from registration to disease progression, assessed up to 3 years
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.
Time from study entry to the date patients end treatment, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Henry Pitot, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 8, 2009

Primary Completion (Actual)

March 13, 2017

Study Completion (Actual)

March 13, 2017

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (Estimate)

November 9, 2009

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02086 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • N01CM62201 (U.S. NIH Grant/Contract)
  • N01CM62204 (U.S. NIH Grant/Contract)
  • P30CA015083 (U.S. NIH Grant/Contract)
  • N01CM62203 (U.S. NIH Grant/Contract)
  • N01CM62207 (U.S. NIH Grant/Contract)
  • N01CM62205 (U.S. NIH Grant/Contract)
  • N01CM62209 (U.S. NIH Grant/Contract)
  • N01CM00070 (U.S. NIH Grant/Contract)
  • N01CM00039 (U.S. NIH Grant/Contract)
  • N01CM00071 (U.S. NIH Grant/Contract)
  • N01CM00099 (U.S. NIH Grant/Contract)
  • N01CM62206 (U.S. NIH Grant/Contract)
  • N01CM00038 (U.S. NIH Grant/Contract)
  • N01CM00100 (U.S. NIH Grant/Contract)
  • NCI-2011-02504
  • MC0845
  • CDR0000653790
  • NCI-2012-01049
  • 8233 (Other Identifier: CTEP)
  • N01CM00032 (U.S. NIH Grant/Contract)
  • N01CM62208 (U.S. NIH Grant/Contract)
  • P50CA102701 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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