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Trial record 48 of 174 for:    pertuzumab

Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers

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.
 
ClinicalTrials.gov Identifier: NCT01121939
Recruitment Status : Completed
First Posted : May 12, 2010
Results First Posted : September 23, 2015
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Tracking Information
First Submitted Date  ICMJE May 10, 2010
First Posted Date  ICMJE May 12, 2010
Results First Submitted Date  ICMJE February 26, 2015
Results First Posted Date  ICMJE September 23, 2015
Last Update Posted Date February 5, 2016
Study Start Date  ICMJE May 2010
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
Objective Response Rate (ORR) [ Time Frame: 18 months ]
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
To determine overall response rate of patients with low grade neuroendocrine cancer when treated with the combination of overall response rate [ Time Frame: 18 months ]
To determine overall response rate of patients with low grade neuroendocrine cancer when treated with the combination of bevacizumab, pertuzumab and sandostatin LAR®.
Change History Complete list of historical versions of study NCT01121939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • Define Toxicity and Safety [ Time Frame: 18 months ]
    To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer - defined by grade 3/4, treatment-related toxicity
  • Progression-Free Survival (PFS) [ Time Frame: 18 months ]
    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
  • Overall Survival (OS) [ Time Frame: 18 months ]
    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
  • Disease Control Rate [ Time Frame: 18 months ]
    The Percentage of Patients Who Experience an Objective Benefit From Treatment or Experience Stable Disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither Sufficient Shrinkage to Qualify For PR, Nor Sufficient Increase to Qualify for Progressive Disease; Disease Control Rate = CR + PR + SD.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
define the toxicity and safety [ Time Frame: 18 months ]
To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers
Official Title  ICMJE Phase II Study of the Combination of Bevacizumab, Pertuzumab, and Sandostatin for Patients With Advanced Neuroendocrine Cancers.
Brief Summary

The purpose of this Phase II trial will be to define the activity of a VEGF inhibitor

bevacizumab, HER1/HER2 inhibitor pertuzumab, and sandostatin for patients with

advanced neuroendocrine cancers. In particular, the efficacy of bevacizumab and

pertuzumab treatment is of great interest. The primary endpoint of this trial will be

response rate. Toxicity and progression-free survival will be obtained and evaluated.

Detailed Description
  • To determine overall response rate of patients with low grade neuroendocrine cancer when treated with the combination of bevacizumab, pertuzumab and sandostatin LAR®.
  • To determine the disease control rate (objective response + stable disease), time to treatment progression, progression-free survival, and overall survival in patients with advanced low grade neuroendocrine cancer when treated with bevacizumab, pertuzumab and Sandostatin LAR® treatment.
  • To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer.
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 Carcinoma
Intervention  ICMJE
  • Drug: Bevacizumab

    15 mg/kg IV Day 1. The first dose should be administered over

    90 minutes. If no adverse reactions occur after the initial dose, the second dose should

    be administered over a minimum of 60 minutes. If no adverse reactions occur after the

    second dose, all subsequent doses should be administered over a minimum of 30

    minutes. Bevacizumab will be infused prior to pertuzumab.

    Other Name: Avastin
  • Drug: Pertuzumab

    840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes. Otherwise, pertuzumab should be infused over 60 minutes. Patients should be observed for 30 minutes after completing the pertuzumab infusion.

    If a patient misses a dose of pertuzumab for 1 cycle (i.e., 2 sequential cycles or administrations are 6 weeks or more apart), a re-loading dose (840 mg) of pertuzumab should be given. If re-loading pertuzumab is administered, subsequent doses of 420 mg will then be given every 3 weeks, starting 3 weeks later.

    Other Names:
    • Omnitarg
    • 2C4
  • Drug: Sandostatin LAR® Depot
    30 mg will be given every 28 days by IM injection. The dose of sandostatin may be increased, at the discretion of the treating physician, if necessary to control symptoms related to tumor secretion of vasoactive peptides.
    Other Name: Octreotide
Study Arms  ICMJE Experimental: 1
combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers
Interventions:
  • Drug: Bevacizumab
  • Drug: Pertuzumab
  • Drug: Sandostatin LAR® Depot
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2010)
43
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with biopsy-proven advanced, unresectable or metastatic, well-differentiated (or low-grade) neuroendocrine carcinoma, including typical carcinoid, pancreatic islet cell and other well-differentiated neuroendocrine carcinomas.
  2. Patients with documented evidence of disease progression.
  3. Patients currently receiving or previously treated with single agent Sandostatin LAR® are eligible.
  4. Patients must have >=1 unidimensional measurable lesion definable by

    MRI or CT scan. Disease must be measurable per RECIST version 1.1 criteria.

  5. Left Ventricular Ejection Fraction (LVEF) >=50% as determined by either ECHO or MUGA <=6 weeks prior to study entry.
  6. An ECOG Performance Status of 0-2.
  7. Laboratory values as follows:

    • ANC >=1500/μL
    • Hgb >=9 g/dL
    • Platelets >=100,000/μL
    • AST/SGOT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases
    • ALT/SGPT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases
    • Bilirubin <=1.5 x ULN
    • Creatinine <=2.0 mg/dL or calculated creatinine clearance >=50 mL/min
  8. Patients >=18 years of age.
  9. Patients must have a life expectancy >12 weeks.
  10. Patient must be accessible for treatment and follow-up.
  11. Women of childbearing potential must have a negative serum or urine pregnancy test performed <=7 days prior to start of treatment. Women of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  12. Patients must be able to understand the nature of the study and give

written informed consent, and comply with study requirements

Exclusion Criteria:

  1. Patients with poorly differentiated neuroendocrine carcinoma, highgrade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, atypical carcinoid, anaplastic carcinoid, and small cell carcinoma are not eligible.
  2. Previous treatment with VEGF or EGFR inhibitors.
  3. Cytotoxic chemotherapy, immunotherapy or radiotherapy <=4 weeks prior to study entry.
  4. History or known presence of central nervous system (CNS) metastases.
  5. Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury <=4 weeks prior to beginning treatment.
  6. Female patients who are pregnant or lactating.
  7. History of hypersensitivity to active or inactive excipients of any component of treatment (bevacizumab, sandostatin, and/or pertuzumab).
  8. Patients with proteinuria at screening as demonstrated by urine dipstick for proteinuria >=2+ (patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection, and must demonstrate <=1 g of protein/24 hours to be eligible).
  9. Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
  10. Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
  11. Patients with history of hematemesis or hemoptysis (defined as having bright red blood of ½ teaspoon or more per episode) <=1 month prior to study enrollment.
  12. History of myocardial infarction or unstable angina <=6 months prior to beginning treatment.
  13. Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and /or diastolic blood pressure >100 mmHg while on antihypertensive medications). Initiation of antihypertensive agents is permitted provided adequate control is documented at least 1 week prior to Day of study treatment.
  14. New York Heart Association (NYHA) grade II or greater congestive

    heart failure (CHF).

  15. Serious cardiac arrhythmia requiring medication.
  16. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) <=6 months prior to Day 1 of treatment.
  17. History of stroke or transient ischemic attack <=6 months prior to beginning treatment.
  18. Any prior history of hypertensive crisis or hypertensive encephalopathy.
  19. History of abdominal fistula or gastrointestinal perforation <=6 months prior to Day 1 of beginning treatment.
  20. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  21. Any known positive test for human immunodeficiency virus, hepatitis C virus or acute or chronic hepatitis B infection.
  22. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  23. Use of any non-approved or investigational agent <=28 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
  24. Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS >=5 years.
  25. Infection requiring IV antibiotics.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT01121939
Other Study ID Numbers  ICMJE SCRI GI 135
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SCRI Development Innovations, LLC
Study Sponsor  ICMJE SCRI Development Innovations, LLC
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Study Chair: Johanna C Bendell, S.B., M.D. SCRI Development Innovations, LLC
PRS Account SCRI Development Innovations, LLC
Verification Date January 2016

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