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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This study has been withdrawn prior to enrollment.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

July 28, 2010
July 25, 2013
July 2013
July 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01172717 on ClinicalTrials.gov Archive Site
Quality of LIfe [ Time Frame: Day 1 each cycle and 1 month follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Panitumumab in the Treatment of Carcinoid Syndrome
Phase II Study of Panitumumab in the Treatment of Carcinoid Syndrome

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoid Syndrome
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
Experimental: Panitumumab
Single arm study
Intervention: Drug: Panitumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01172717
H-31701
Yes
Boston Medical Center
Boston Medical Center
Amgen
Principal Investigator: Kevan Hartshorn, MD Boston Medical Center
Boston Medical Center
July 2013

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