Comparison of Lanreotide Autogel┬« and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
Information source: Ipsen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Carcinoid Syndrome
Intervention: lanreotide Autogel (somatostatin analogue) (Drug); Sandostatin long acting release (LAR) Depot (somatostatin analogue) (Drug)
Phase: Phase 3
Sponsored by: Ipsen
Official(s) and/or principal investigator(s):
France Catus, MD, Study Director, Affiliation: Ipsen
The aim of this study is to compare the efficacy and safety of lanreotide Autogel and
Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce
a similar clinical response in patients with carcinoid syndrome.
Official title: A Phase III, Prospective, Multicenter, Randomized, Open, Parallel Group Comparison of Lanreotide Autogel« (90 and 120 mg) Administered by Deep Subcutaneous Injection Every Four Weeks, With Sandostatin LAR Depot (20 and 30 mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: Target symptom frequency (flushing or stool frequency).
Minimum age: 18 Years.
Maximum age: N/A.
- Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type.
- Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to a
primary tumor of the lung, stomach or mid-gut.
- Previous positive Octreoscan.
- World Health Organization (WHO) performance score lower than 2.
At the baseline visit patients MUST satisfy the following criteria before they are
randomized to receive study treatment:
- Stool and/or flushing frequency of greater than or equal to 3 episodes/day (average
over a minimum five consecutive days).
- Patients who have previously been treated with somatostatin analogues must have
discontinued treatment for a sufficient period of time (a washout period of at least 7
days for immediate release formulations and up to 2 months for prolonged release
formulations is usually required). Compared with their "controlled" state on
treatment, these patients must show a clinically significant deterioration (at least
two episodes) of either symptom. For example, a patient considered to be controlled
on their previous treatment with an estimated stool frequency of two episodes per day,
must achieve a stool frequency of at least four episodes per day (average over a
minimum five consecutive days).
- WHO performance score lower than 2.
- VIPoma or other non-carcinoid tumor.
- Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to
inclusion, or planned during the study.
- Radionuclide treatment within three months prior to inclusion, or planned during the
- Presence of other active malignant pathology (except basal cellular carcinoma of the
skin and/or in situ carcinoma of the cervix/uterus).
- Surgical procedure or embolization procedure (with or without cytotoxic agents) of the
tumor within three months prior to inclusion, or planned during the study.
- Life expectancy of less than 6 months.
- Any investigational drug given within 30 days prior to inclusion or expected to be
given during the study.
- No access to a telephone for completion of the daily telephone diary.
Locations and Contacts
Larry Kvols, MD, Tampa, Florida 33612, United States
Starting date: July 2004
Ending date: October 2004
Last updated: February 25, 2008