Study of Panitumumab in the Treatment of Carcinoid Syndrome

NCT01172717 | Withdrawn Phase 2 DMC

• 1 other identifier: H-31701
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Carcinoid Syndrome

Keywords

Carcinoid; Carcinoid syndrome

Outcome Measures

Primary Outcomes (2)

• Radiographic measures

  Every 4 cycles

• Tumor Marker Evaluations

  Every 2 cycles

Secondary Outcomes (1)

• Quality of LIfe

  Day 1 each cycle and 1 month follow-up

Study Arms (1)

Panitumumab

EXPERIMENTAL

Single arm study

Drug: Panitumumab

Interventions

Panitumumab DRUG

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

Also known as: Vectibix, ABX-EGF

Panitumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of metastatic carcinoid tumor and carcinoid syndrome
• Measurable disease as defined by RECIST criteria or evaluable disease
• 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.
• 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.
• 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.
• Absolute neutrophil count greater than or equal to 1.5 x 109/L
• Hemoglobin greater than or equal to 9.0 g/dL
• Platelet count greater than or equal to 100 x 109/L
• Serum creatinine less than 1.5 mg/dL
• 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.
• 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.

You may not qualify if:

• 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).
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of enrollment.
• A negative octreotide scan does not exclude study enrollment.

Sponsors & Collaborators

• Boston Medical Center: lead
• Amgen: collaborator

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Serotonin Syndrome; Carcinoid Tumor

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kevan Hartshorn, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 30, 2010
• Study Start: July 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

US (2)