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

This study has been terminated.
(Extreme toxicity of Pertuzumab and Erlotinib combination)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Pamela L. Kunz, Stanford University
ClinicalTrials.gov Identifier:
NCT00947167
First received: July 23, 2009
Last updated: November 9, 2011
Last verified: November 2011

July 23, 2009
November 9, 2011
March 2009
May 2010   (final data collection date for primary outcome measure)
  • Response rate (RR) for all patients treated with this strategy (Simon design) [ Time Frame: CT scans are done every 4 cycles (every 12 wks) ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) after erlotinib in stable patients if Simon design ends early with few progressions. [ Time Frame: CT scans are done every 4 cycles (every 12 wks) ] [ Designated as safety issue: No ]
  • RR for all patients treated with this strategy (Simon design)
  • PFS after erlotinib in stable patients if Simon design ends early with few progressions.
Complete list of historical versions of study NCT00947167 on ClinicalTrials.gov Archive Site
  • PFS for all patients treated with this strategy [ Time Frame: CT scans are done every 4 cycles (every 12 wk) ] [ Designated as safety issue: No ]
  • Toxicities assessed by CTCAE grading criteria and assigned attributions accordingly [ Time Frame: AEs are assessed every cycle (every 3 wks) ] [ Designated as safety issue: Yes ]
  • RR for patients treated with combination of pertuzumab and erlotinib [ Time Frame: CT scans are done every 4 cycles (every 12 wks) ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors
A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neuroendocrine Tumors
  • Carcinoid Tumors
  • Adrenal Gland Tumors
  • Neuroblastoma
  • Pancreatic Neuroendocrine Tumors
  • Multiple Endocrine Neoplasia
  • Drug: pertuzumab
    840 mg, 420 mg, iv
    Other Names:
    • 2C4
    • Omnitarg
    • Genentech
  • Drug: erlotinib
    150 mg, PO
    Other Names:
    • Tarceva
    • Erlotinib hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00947167
END0008, SU-03272009-2039
Yes
Pamela L. Kunz, Stanford University
Pamela L. Kunz
Genentech, Inc.
Principal Investigator: Pamela Kunz Stanford University
Stanford University
November 2011

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