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Phase II Study of Panitumumab in the Treatment of Carcinoid Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoid Syndrome

Thank you

Trial Information

Phase II Study of Panitumumab in the Treatment of Carcinoid Syndrome


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Radiographic measures

Outcome Time Frame:

Every 4 cycles

Safety Issue:

No

Principal Investigator

Kevan Hartshorn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

H-31701

NCT ID:

NCT01172717

Start Date:

July 2013

Completion Date:

July 2016

Related Keywords:

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

Name

Location

Boston Medical CenterBoston, Massachusetts  02118
Lahey ClinicBurlington, Massachusetts  01805