Study of Panitumumab in the Treatment of Carcinoid Syndrome

This study has been withdrawn prior to enrollment.
(Study never began)
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01172717
First received: July 28, 2010
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

The primary hypothesis of this study is that panitumumab, an inhibitor of the epidermal growth factor receptor (EGFR), is an effective treatment for carcinoid syndrome in people who fail or do not adequately respond to octreotide or other supportive therapies.


Condition Intervention Phase
Carcinoid Syndrome
Drug: Panitumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Panitumumab in the Treatment of Carcinoid Syndrome

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Radiographic measures [ Time Frame: Every 4 cycles ] [ Designated as safety issue: No ]
  • Tumor Marker Evaluations [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of LIfe [ Time Frame: Day 1 each cycle and 1 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panitumumab
Single arm study
Drug: Panitumumab
Panitumumab will be given by intravenous infusion at a dose of 9 mg/kg on day 1 of study and then every 3 weeks until progression of disease
Other Names:
  • Vectibix
  • ABX-EGF

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of metastatic carcinoid tumor and carcinoid syndrome
  • Measurable disease as defined by RECIST criteria or evaluable disease

    1. Measurable disease is the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions are lesions that can be accurately measured in at least one dimension with longest diameter greater than or equal to 20 mm using conventional techniques or greater than or equal to 10 mm with spiral CT scan.
    2. Evaluable disease is disease that cannot be measured directly by the size of the tumor but can be evaluated by a validated biomarker assay including 24 hr urine 5-hydroxyindoleacetic acid, serum serotonin, and/or serum chromogranin A.
    3. All sites of disease must be evaluated less than or equal to 28 days prior to enrollment.
  • All subjects must be 18 years of age or older.
  • ECOG performance status of 0 to 2.
  • Subjects may have had past or may be receiving current treatment with octreotide.
  • Adequate laboratory parameters with all tests to be performed within 72 hours prior to the first dose.

    1. Absolute neutrophil count greater than or equal to 1.5 x 109/L
    2. Hemoglobin greater than or equal to 9.0 g/dL
    3. Platelet count greater than or equal to 100 x 109/L
    4. Serum creatinine less than 1.5 mg/dL
    5. Aspartate aminotransferase (AST) less than or equal to 3 times the upper limit of normal, unless with radiographic evidence of liver metastases. If with liver metastases, AST less than 5 times the upper limit of normal.
    6. Alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal, unless with radiographic evidence of liver metastases. If with liver metastases, AST less than 5 times the upper limit of normal.
    7. Total Bilirubin less than or equal to 1.5 times the upper limit of normal.
    8. Magnesium level greater than lower limit of normal
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Woman and men should use adequate birth control for at least 6 months after the last administration of panitumumab.
  • Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.

Exclusion Criteria:

  • Evidence of localized carcinoid tumor amenable to surgical resection or chemoembolization.
  • People who are asymptomatic from their carcinoid tumors.
  • Past treatment with EGFR inhibitors including cetuximab and panitumumab.
  • History of active malignancies requiring treatment in the past 5 years with the exception of resected basal cell carcinoma of the skin.
  • History of interstitial pneumonitis or pulmonary fibrosis.
  • History of cardiac arrhythmia or Q-T prolongation on electrocardiogram.
  • Women who are pregnant or breast feeding.
  • Known infection with human immunodeficiency virus (HIV).
  • Treatment with chemotherapy, biologics, immunotherapy, vaccines or cytokine therapy within 4 weeks prior to study entry. The use of octreotide is not exclusionary.
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of enrollment.
  • A negative octreotide scan does not exclude study enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172717

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Boston Medical Center
Amgen
Investigators
Principal Investigator: Kevan Hartshorn, MD Boston Medical Center
  More Information

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01172717     History of Changes
Other Study ID Numbers: H-31701
Study First Received: July 28, 2010
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Medical Center:
Carcinoid
Carcinoid syndrome

Additional relevant MeSH terms:
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug Toxicity
Poisoning
Substance-Related Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014