Status:
TERMINATED
Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
Lead Sponsor:
Ipsen
Conditions:
Malignant Carcinoid Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 study.
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00092287
Start Date
July 1 2004
End Date
October 1 2004
Last Update
April 30 2020
Active Locations (1)
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1
Larry Kvols, MD
Tampa, Florida, United States, 33612