A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors

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. Identifier: NCT00947167
Recruitment Status : Terminated (Extreme toxicity of Pertuzumab and Erlotinib combination)
First Posted : July 27, 2009
Results First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Genentech, Inc.
Information provided by (Responsible Party):
Pamela L. Kunz, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Neuroendocrine Tumors
Carcinoid Tumors
Adrenal Gland Tumors
Pancreatic Neuroendocrine Tumors
Multiple Endocrine Neoplasia
Interventions: Drug: pertuzumab
Drug: erlotinib

  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
Pertuzumab and Erlotinib

pertuzumab: 840 mg, 420 mg, iv

erlotinib: 150 mg, PO

Participant Flow for 2 periods

Period 1:   Pertuzumab Alone
    Pertuzumab and Erlotinib

Period 2:   Erlotinib Added to Pertuzumab
    Pertuzumab and Erlotinib

  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.
No text entered.

Reporting Groups
Pertuzumab and Erlotinib

pertuzumab: 840 mg, 420 mg, iv

erlotinib: 150 mg, PO

Baseline Measures
   Pertuzumab and Erlotinib 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      4 100.0% 
>=65 years      0   0.0% 
[Units: Years]
Mean (Full Range)
 (34 to 55) 
[Units: Participants]
Count of Participants
Female      2  50.0% 
Male      2  50.0% 

  Outcome Measures

1.  Primary:   Response Rate (RR) for All Patients Treated With This Strategy (Simon Design)   [ Time Frame: CT scans are done every 4 cycles (every 12 wks) ]

2.  Secondary:   Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly   [ Time Frame: AEs are assessed every cycle (every 3 wks) ]

  Serious Adverse Events

  Other Adverse Events

  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
Early termination due to toxicity, thus small number of patients analyzed and limited statistical power.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.

Results Point of Contact:  
Name/Title: Pamela L. Kunz, MD, Leader GI Oncology Research Group
Organization: Stanford University School of Medicine
phone: 650-725-8738

Responsible Party: Pamela L. Kunz, Stanford University Identifier: NCT00947167     History of Changes
Other Study ID Numbers: NET0008
16186 ( Other Identifier: Stanford IRB )
END0008 ( Other Identifier: Old OnCore Number )
First Submitted: July 23, 2009
First Posted: July 27, 2009
Results First Submitted: January 12, 2017
Results First Posted: March 3, 2017
Last Update Posted: March 3, 2017