Study of Panitumumab in the Treatment of Carcinoid Syndrome

Phase II Study of Panitumumab in the Treatment of Carcinoid Syndrome

NCT01172717•Boston Medical Center

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+10 more criteria

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.
+1 more criteria

Locations (2)

Boston Medical Center

Boston, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

Key Dates

Start Date

July 1, 2013

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

July 26, 2013

Conditions

Carcinoid Syndrome

Interventions

Panitumumab

DRUG

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TERMINATEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Study of Panitumumab in the Treatment of Carcinoid Syndrome

Inclusion Criteria

Exclusion Criteria

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