Study of Panitumumab in the Treatment of Carcinoid Syndrome

Carcinoid Syndrome Clinical Trial

Official title:

Phase II Study of Panitumumab in the Treatment of Carcinoid Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01172717
• Other study ID #: H-31701
• Status: Withdrawn
• Phase: Phase 2
• First received: July 28, 2010
• Last updated: July 25, 2013
• Start date: July 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Syndrome
• Carcinoid Tumor
• Malignant Carcinoid Syndrome
• Serotonin Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic measures		Every 4 cycles	No
Primary	Tumor Marker Evaluations		Every 2 cycles	No
Secondary	Quality of LIfe		Day 1 each cycle and 1 month follow-up	No