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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

Tracking Information
First Submitted Date  ICMJE July 23, 2009
First Posted Date  ICMJE July 27, 2009
Results First Submitted Date  ICMJE January 12, 2017
Results First Posted Date  ICMJE March 3, 2017
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE March 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
Response Rate (RR) for All Patients Treated With This Strategy (Simon Design) [ Time Frame: CT scans are done every 4 cycles (every 12 wks) ]
RECIST v1.1 used
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
  • RR for all patients treated with this strategy (Simon design)
  • PFS after erlotinib in stable patients if Simon design ends early with few progressions.
Change History Complete list of historical versions of study NCT00947167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly [ Time Frame: AEs are assessed every cycle (every 3 wks) ]
by CTCAE
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
  • PFS for all patients treated with this strategy
  • Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly
  • RR for patients treated with combination of pertuzumab and erlotinib
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors
Official Title  ICMJE A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors
Brief Summary To determine objective response rates (RR) by RECIST guideline version 1.1 for all patients treated with this strategy consisting of initial therapy with pertuzumab as a single agent and then addition of erlotinib for those who have stable disease or progressive disease at three months (Simon design).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuroendocrine Tumors
  • Carcinoid Tumors
  • Adrenal Gland Tumors
  • Neuroblastoma
  • Pancreatic Neuroendocrine Tumors
  • Multiple Endocrine Neoplasia
Intervention  ICMJE
  • Drug: pertuzumab
    840 mg, 420 mg, iv
    Other Names:
    • 2C4
    • Omnitarg
    • Genentech
  • Drug: erlotinib
    150 mg, PO
    Other Names:
    • Tarceva
    • Erlotinib hydrochloride
Study Arms  ICMJE Experimental: Pertuzumab and Erlotinib
Interventions:
  • Drug: pertuzumab
  • Drug: erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 9, 2011)
4
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2009)
40
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects must be treated at Stanford University Medical Center for the entire length of study participation.

  1. Patients must have histologically or cytologically confirmed well-differentiated neuroendocrine tumor. Patients must be deemed unresectable due to involvement of critical vasculature or adjacent organ invasion or have metastatic disease.
  2. Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.
  3. Prior chemotherapy will be permitted.
  4. Prior or concurrent somatostatin analogue use will be permitted.
  5. Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria (v1.1) within 4 weeks prior to entry of study.
  6. Patients must have ECOG performance status of 0-2.
  7. Patients must be >= 18 years of age.
  8. Laboratory values <= 2 weeks prior to randomization:

    • Absolute Neutrophil Count (ANC) >= 1.5 x 109/L (>= 1500/mm3)
    • Platelets (PLT) >= 50 x 109/L (>= 100,000/mm3) (or >= 25 x 109/L (>= 100,000/mm3) if thrombocytopenia is secondary to a non-myelosuppressive cause such as splenic sequestration).
    • Hemoglobin (Hgb) >= 9 g/dL
    • Serum creatinine <= 1.5 x ULN
    • Serum bilirubin <= 1.5 x ULN (<= 3.0 x ULN if liver metastases present)
    • Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) <= 3.0 x ULN (<= 5.0 x ULN if liver metastases present). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests.
    • Albumin >= 1.5
  9. LVEF by TTE or MUGA >= 50%
  10. Life expectancy >= 12 weeks
  11. Ability to give written informed consent according to local guidelines

Exclusion Criteria:

  1. Disease-Specific Exclusions

    1. Prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
    2. Prior biologic or immunotherapy <= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
    3. If history of other primary cancer, subject will be eligible only if she or he has:

      • Curatively resected non-melanomatous skin cancer
      • Curatively treated cervical carcinoma in situ
      • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
    4. Concurrent use of other investigational agents and patients who have received investigational drugs <= 4 weeks prior to enrollment.
  2. General Medical Exclusions

    1. Subjects known to have chronic or active hepatitis B or C infection with impaired hepatic function (ineligible if AST and ALT > 3.0 x ULN).
    2. History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
    3. Male subject who is not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of second-line treatment
    4. Female subject (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) who is not willing to use an oral, patch or implanted contraceptive, double-barrier birth control, or an IUD during the course of the study and for 6 months following the last dose of second-line treatment
    5. Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization
    6. Pleural effusion or ascites that causes respiratory compromise (>= CTCAE grade 2 dyspnea)
    7. Any of the following concurrent severe and/or uncontrolled medical conditions within 24 weeks of enrollment which could compromise participation in the study:

      • Unstable angina pectoris
      • Symptomatic congestive heart failure
      • Myocardial infarction <= 6 months prior to registration and/or randomization
      • Serious uncontrolled cardiac arrhythmia
      • Uncontrolled diabetes
      • Active or uncontrolled infection
      • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
      • Chronic renal disease
    8. Patients unwilling to or unable to comply with the protocol
    9. Life expectancy of less than 12 weeks
    10. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored cancer study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947167
Other Study ID Numbers  ICMJE NET0008
SU-03272009-2039
16186 ( Other Identifier: Stanford IRB )
END0008 ( Other Identifier: Old OnCore Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pamela L. Kunz, Stanford University
Study Sponsor  ICMJE Pamela L. Kunz
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Pamela Kunz Stanford University
PRS Account Stanford University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP