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A Double-blind, Randomized Placebo-controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoid Syndrome

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Trial Information

A Double-blind, Randomized Placebo-controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome


Inclusion Criteria:



- histopathologically confirmed diagnosis of carcinoid tumor or a carcinoid tumor of
unknown location with liver metastases

- history of carcinoid syndrome (flushing and/or diarrhea)

- either naive to treatment with a Somatostatin analog or responsive to conventional
doses of LAR or subcutaneous octreotide

- confirmation of positive somatostatin receptor status by somatostatin receptor
scintigraphy

- absence of tumor progression

Exclusion Criteria:

- history of carcinoid syndrome refractory to treatment with conventional doses of
Somatostatin analogs

- treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled
Somatostatin analog and/or tumor debulking < 3 months prior to study entry

- history of hepatic arterial embolization

- short bowel syndrome

- uncontrolled diabetes and/or hypertension

- severe renal impairment and/or liver impairment

- diagnosis of cardiac disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Usage of subcutaneous octreotide to control symptoms associated with carcinoid syndrome, measured as the % of days that subcutaneous octreotide is used as rescue medication based on patient IVRS diary records

Outcome Time Frame:

16 week double-blind phase of the study

Safety Issue:

No

Principal Investigator

Edda Gomez-Panzani, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

United States: Food and Drug Administration

Study ID:

2-55-52030-730

NCT ID:

NCT00774930

Start Date:

March 2009

Completion Date:

December 2015

Related Keywords:

  • Carcinoid Syndrome
  • carcinoid tumor
  • Carcinoid Tumor
  • Malignant Carcinoid Syndrome
  • Serotonin Syndrome

Name

Location

University of Michigan Ann Arbor, Michigan  48109-0624
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Eastern Virginia Medical School Norfolk, Virginia  23507
Stanford Cancer Center Stanford, California  94305-5824
University of Pennsylvania Philadelphia, Pennsylvania  19104
Kentuckiana Cancer Institute Louisville, Kentucky  40202
Providence Portland Medical Center Portland, Oregon  97213-3635
UPMC Liver Cancer Center Pittsburgh, Pennsylvania  15213
Louisiana State University Health Science Center New Orleans, Louisiana  70112
David Geffen School of Medicine at UCLA Los Angeles, California  90095
Oregon Health Science University Portland, Oregon  97239
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
VA Greater Los Angeles Health Care System West Los Angeles, California  90073
Cedars Sinai Outpatient Cancer Center West Hollywood, California  90048
University of New Mexico Cancer Care Center Albuquerque, New Mexico  97239
Froedtert & Medical College of Wisconsin Milwaukee, Wisconsin  53226