Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor (S0518)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00569127
First received: December 5, 2007
Last updated: June 20, 2016
Last verified: June 2016
Results First Received: February 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neuroendocrine Carcinoma
Interventions: Biological: Recombinant Interferon Alfa-2b
Drug: Octreotide Acetate
Biological: Bevacizumab

  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
No text entered.

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
Octreotide, Bevacizumab Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Octreotide, Interferon Alpha-2b Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Octreotide, Bevacizumab     Octreotide, Interferon Alpha-2b  
STARTED     214     213  
Eligible     200     202  
COMPLETED     0     0  
NOT COMPLETED     214     213  
Adverse Event                 57                 47  
Withdrawal by Subject                 13                 27  
Progression                 99                 100  
Death                 4                 3  
Not Specified                 20                 19  
Lost to Follow-up                 0                 3  
Not Eligible                 14                 11  
Still on Treatment                 7                 3  



  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.
Eligible patients

Reporting Groups
  Description
Octreotide, Bevacizumab Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Octreotide, Interferon Alpha-2b Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Octreotide, Bevacizumab     Octreotide, Interferon Alpha-2b     Total  
Number of Participants  
[units: participants]
  200     202     402  
Age  
[units: years]
Median (Full Range)
  60.5  
  (27.2 to 85.3)  
  61.1  
  (23.1 to 85.4)  
  60.9  
  (23.1 to 85.4)  
Gender  
[units: participants]
     
Female     98     112     210  
Male     102     90     192  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     13     11     24  
Not Hispanic or Latino     166     177     343  
Unknown or Not Reported     21     14     35  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     2     4     6  
Native Hawaiian or Other Pacific Islander     2     0     2  
Black or African American     18     20     38  
White     169     167     336  
More than one race     4     0     4  
Unknown or Not Reported     3     11     14  
Disease Site  
[units: participants]
     
Small bowel, cecum, appendix     71     72     143  
Other sites     129     130     259  
Progression after Initial Diagnosis  
[units: participants]
     
Yes     182     188     370  
No     18     14     32  
Histologic Grade  
[units: participants]
     
Low     169     171     340  
Intermediate (atypical)     31     31     62  
Prior Octreotide  
[units: participants]
     
Within 2 months prior to registration     114     115     229  
None within 2 months prior to registration     86     87     173  



  Outcome Measures
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1.  Primary:   Central Review-based Progression-Free Survival   [ Time Frame: Up to 3 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 7 years ]

3.  Secondary:   Time to Treatment Failure   [ Time Frame: Up to 3 years ]

4.  Secondary:   Local Progression-Free Survival (Investigator Assessed)   [ Time Frame: Up to 3 years ]

5.  Secondary:   Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)   [ Time Frame: Up to 3 years ]

6.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: 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
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  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: SWOG Statistician
Organization: SWOG
phone: 206-667-4408



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00569127     History of Changes
Other Study ID Numbers: NCI-2009-00778
NCI-2009-00778 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000579151
SWOG-S0518
S0518 ( Other Identifier: SWOG )
S0518 ( Other Identifier: CTEP )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: December 5, 2007
Results First Received: February 18, 2016
Last Updated: June 20, 2016
Health Authority: United States: Food and Drug Administration