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Trial record 57 of 173 for:    pertuzumab

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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
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
Neuroblastoma
Pancreatic Neuroendocrine Tumors
Multiple Endocrine Neoplasia
Interventions Drug: pertuzumab
Drug: erlotinib
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab and Erlotinib
Hide Arm/Group Description

pertuzumab: 840 mg, 420 mg, iv

erlotinib: 150 mg, PO

Period Title: Pertuzumab Alone
Started 4
Completed 4
Not Completed 0
Period Title: Erlotinib Added to Pertuzumab
Started 3
Completed 3
Not Completed 0
Arm/Group Title Pertuzumab and Erlotinib
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pertuzumab: 840 mg, 420 mg, iv

erlotinib: 150 mg, PO

Overall Number of Baseline Participants 4
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
46.5
(34 to 55)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
1.Primary Outcome
Title Response Rate (RR) for All Patients Treated With This Strategy (Simon Design)
Hide Description RECIST v1.1 used
Time Frame CT scans are done every 4 cycles (every 12 wks)
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Hide Analysis Population Description
whole cohort
Arm/Group Title Pertuzumab and Erlotinib
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pertuzumab: 840 mg, 420 mg, iv

erlotinib: 150 mg, PO

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly
Hide Description by CTCAE
Time Frame AEs are assessed every cycle (every 3 wks)
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Hide Analysis Population Description
whole cohort
Arm/Group Title Pertuzumab and Erlotinib
Hide Arm/Group Description:

pertuzumab: 840 mg, 420 mg, iv

erlotinib: 150 mg, PO

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
Time Frame 4 years
Adverse Event Reporting Description We followed patients until death
 
Arm/Group Title Pertuzumab and Erlotinib
Hide Arm/Group Description

pertuzumab: 840 mg, 420 mg, iv

erlotinib: 150 mg, PO

All-Cause Mortality
Pertuzumab and Erlotinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab and Erlotinib
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pertuzumab and Erlotinib
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  3/4 (75.00%)  3
Leukocytes  1  1/4 (25.00%)  1
Platelets  1  1/4 (25.00%)  1
Gastrointestinal disorders   
Anorexia  1  2/4 (50.00%)  2
Diarrhea  1  4/4 (100.00%)  4
Mucositis  1  1/4 (25.00%) 
Nausea  1  2/4 (50.00%)  2
Taste  1  1/4 (25.00%)  1
Vomiting  1  3/4 (75.00%)  3
Hemorrhage  1  1/4 (25.00%)  1
General disorders   
Fatigue  1  4/4 (100.00%)  4
Sweating  1  1/4 (25.00%)  1
Metabolism and nutrition disorders   
Albumin low  1  1/4 (25.00%)  1
Alkaline Phosphatase elevation  1  1/4 (25.00%)  1
ALT elevation  1  3/4 (75.00%)  3
AST elevation  1  2/4 (50.00%)  2
Calcium low  1  1/4 (25.00%)  1
Potassium low  1  1/4 (25.00%)  1
Skin and subcutaneous tissue disorders   
Hair loss  1  1/4 (25.00%)  1
Rash  1  4/4 (100.00%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Early termination due to toxicity, thus small number of patients analyzed and limited statistical power.
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
Layout table for Results Point of Contact information
Name/Title: Pamela L. Kunz, MD, Leader GI Oncology Research Group
Organization: Stanford University School of Medicine
Phone: 650-725-8738
EMail: pkunz@stanford.edu
Layout table for additonal information
Responsible Party: Pamela L. Kunz, Stanford University
ClinicalTrials.gov Identifier: NCT00947167     History of Changes
Other Study ID Numbers: NET0008
SU-03272009-2039
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