We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00569127
First Posted: December 6, 2007
Last Update Posted: November 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: February 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neuroendocrine Carcinoma
Interventions: Biological: Recombinant Interferon Alfa-2b
Drug: Octreotide Acetate
Biological: Bevacizumab

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      98  49.0%      112  55.4%      210  52.2% 
Male      102  51.0%      90  44.6%      192  47.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      13   6.5%      11   5.4%      24   6.0% 
Not Hispanic or Latino      166  83.0%      177  87.6%      343  85.3% 
Unknown or Not Reported      21  10.5%      14   6.9%      35   8.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   1.0%      0   0.0%      2   0.5% 
Asian      2   1.0%      4   2.0%      6   1.5% 
Native Hawaiian or Other Pacific Islander      2   1.0%      0   0.0%      2   0.5% 
Black or African American      18   9.0%      20   9.9%      38   9.5% 
White      169  84.5%      167  82.7%      336  83.6% 
More than one race      4   2.0%      0   0.0%      4   1.0% 
Unknown or Not Reported      3   1.5%      11   5.4%      14   3.5% 
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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
  Hide More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: December 5, 2007
First Posted: December 6, 2007
Results First Submitted: February 18, 2016
Results First Posted: April 28, 2016
Last Update Posted: November 16, 2016