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Trial record 1 of 1 for:    CALGB 80701
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Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01229943
First received: October 27, 2010
Last updated: August 15, 2016
Last verified: July 2016
Results First Received: January 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pancreatic Gastrinoma
Pancreatic Neuroendocrine Tumor G1
Pancreatic Neuroendocrine Tumor G2
Pancreatic Vipoma
Recurrent Pancreatic Neuroendocrine Carcinoma
Interventions: Biological: Bevacizumab
Drug: Everolimus
Drug: Octreotide Acetate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From October 2010 to October 2012, 150 participants were recruited and randomized to study treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Octreotide Acetate and Everolimus)

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >

> Octreotide Acetate: Given IM

Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >

> Bevacizumab: Given IV >

> Everolimus: Given PO >

> Octreotide Acetate: Given IM


Participant Flow:   Overall Study
    Arm I (Octreotide Acetate and Everolimus)     Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)  
STARTED     75     75  
COMPLETED     57     58  
NOT COMPLETED     18     17  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Octreotide Acetate and Everolimus)

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >

> Octreotide Acetate: Given IM

Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >

> Bevacizumab: Given IV >

> Everolimus: Given PO >

> Octreotide Acetate: Given IM

Total Total of all reporting groups

Baseline Measures
    Arm I (Octreotide Acetate and Everolimus)     Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)     Total  
Number of Participants  
[units: participants]
  75     75     150  
Age  
[units: years]
Median (Full Range)
  59  
  (23 to 80)  
  58  
  (21 to 86)  
  58.5  
  (21 to 86)  
Gender  
[units: participants]
     
Female     35     31     66  
Male     40     44     84  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     3     1     4  
Not Hispanic or Latino     69     70     139  
Unknown or Not Reported     3     4     7  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     4     2     6  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     4     8     12  
White     64     61     125  
More than one race     0     0     0  
Unknown or Not Reported     2     3     5  
Region of Enrollment  
[units: participants]
     
Canada     5     6     11  
United States     70     69     139  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: From study entry to the date of documented progression or death from any cause, up to 3 years ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Up to 3 years ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: From registration to time of death, assessed up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Matthew Kulke, MD, MMSc
Organization: Dana-Farber Cancer Institute
e-mail: matthew_kulke@dfci.harvard.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01229943     History of Changes
Other Study ID Numbers: NCI-2011-02609
NCI-2011-02609 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000687459
CALGB-80701 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-80701 ( Other Identifier: CTEP )
U10CA180821 ( US NIH Grant/Contract Award Number )
U10CA031946 ( US NIH Grant/Contract Award Number )
Study First Received: October 27, 2010
Results First Received: January 13, 2016
Last Updated: August 15, 2016
Health Authority: United States: Food and Drug Administration