Trial record 3 of 57 for:
Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
This study has been terminated.
Information provided by:
First received: September 22, 2004
Last updated: February 25, 2008
Last verified: February 2008
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.
Malignant Carcinoid Syndrome
Drug: lanreotide Autogel (somatostatin analogue)
Drug: Sandostatin long acting release (LAR) Depot (somatostatin analogue)
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Target symptom frequency (flushing or stool frequency).
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00092287
|Larry Kvols, MD
|Tampa, Florida, United States, 33612 |
||France Catus, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 22, 2004
||February 25, 2008
||United States: Food and Drug Administration
Keywords provided by Ipsen:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Malignant Carcinoid Syndrome
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs