An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome (ELECT)
This study is ongoing, but not recruiting participants.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00774930
First received: October 15, 2008
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome. In countries where Somatuline Depot is not approved, patients well controlled at the end of the open-label phase will be able to participate in a long-term open-label extension phase.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoid Syndrome |
Drug: Somatuline Depot (lanreotide) Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized Placebo-controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- 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 [ Time Frame: 16 week double-blind phase of the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Frequency of diarrhea events (per day) based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
- Frequency of flushing events (per day) based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
- Usage of other rescue medications for diarrhea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on patient IVRS diary records. [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
- Proportion of patients who roll over into the open-label phase before completing the double-blind phase of the study. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Changes from baseline in Quality of Life (QoL); assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30-Carcinoid/NETs module: EORTC QLQ-G.I. NET 21 [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
- Absolute changes from baseline in biochemical marker - plasma Chromogranin A (CgA). [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
- Absolute changes from baseline in biochemical marker - urinary 5-hydroxyindoleacetic acid (5-HIAA). [ Time Frame: 16-week double-blind phase ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Somatuline Depot 120 mg |
Drug: Somatuline Depot (lanreotide)
subcutaneous injection, 120 mg, q28d
Other Name: Somatuline Autogel
|
| Placebo Comparator: Placebo |
Drug: placebo
inactive substance
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774930
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Hide Study LocationsLocations
| United States, California | |
| David Geffen School of Medicine at UCLA | |
| Los Angeles, California, United States, 90095 | |
| VA Greater Los Angeles Health Care System | |
| Los Angeles, California, United States, 90073 | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305 | |
| Cedars Sinai Outpatient Cancer Center | |
| West Hollywood, California, United States, 90048 | |
| United States, Kentucky | |
| Kentuckiana Cancer Institute | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Louisiana State University Health Science Center | |
| Kenner, Louisiana, United States, 70065 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, New Mexico | |
| University of New Mexico Cancer Care Center | |
| Albuquerque, New Mexico, United States, 97239 | |
| United States, Oregon | |
| Oregon Health Science University | |
| Portland, Oregon, United States, 97239 | |
| Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| UPMC Liver Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Virginia | |
| Eastern Virginia Medical School | |
| Norfolk, Virginia, United States, 23510 | |
| United States, Wisconsin | |
| Froedtert & Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Brazil | |
| Biocancer - Centro de Pesquisa e Tratamento do Câncer | |
| Belo Horizonte, Brazil | |
| Oxion Medicina Oncológica | |
| Belo Horizonte, Brazil | |
| Hospital LifeCenter | |
| Belo Horizonte, Brazil | |
| Hospital Universitário de Brasilia | |
| Brasilia, Brazil | |
| Hospital Erasto Gaertner | |
| Curitiba, Brazil | |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | |
| Porto Alegre, Brazil | |
| Hospital de Base de São José do Rio Preto | |
| São José do Rio Preto, Brazil | |
| Czech Republic | |
| VFN Onkologicka klinika | |
| Prague, Czech Republic, 12808 | |
| India | |
| Sir Gangaram Hospital | |
| Delhi, India | |
| Indo-American Cancer Institute & Research Centre | |
| Hyderabad, India | |
| Omega Hospitals | |
| Hyderabad, India | |
| Santokaba Durlabhji Memorial Hospital and Research Institute | |
| Jaipur, India, 302015 | |
| Bhagwan Mahaveer cancer hospital and research centre | |
| Jaipur, India | |
| Tata Memorial Hospital | |
| Mumbai, India | |
| Shatabdi Super Speciality hospital | |
| Nasik, India, 422005 | |
| Latvia | |
| Paul Stradins Clinical University Hospital | |
| Riga, Latvia, 1002 | |
| Poland | |
| Klinika Endokrynologii, Diabetologii i Leczenia Izotopami | |
| Wrocław, Poland, 50-367 | |
| Russian Federation | |
| Non-Federal Institution of Healthcare "Central Clinical Hospital # 1 of the LLC "Russian Railways (RZD)" | |
| Moscow, Russian Federation | |
| Russian Academy of Medical Sciences "Russian Oncological Research Centre named after N.N. Blokhin RAMS" | |
| Moscow, Russian Federation | |
| Federal Institution of Healthcare "Leningradsky Regional Oncological Dispensary" | |
| Saint-Petersburg, Russian Federation | |
| Serbia | |
| Clinic of Endocrinology, diabetes and metabolic diseases, Clinical Center of Serbia | |
| Belgrade, Serbia, 11000 | |
| Oncology Institute of Vojvodina, Sremska Kamenica | |
| Sremska Kamenica, Serbia, 21 204 | |
| South Africa | |
| Rondebosch Oncology Unit | |
| Cape Town, South Africa, 7700 | |
| Groote Schuur Hospital | |
| Cape Town, South Africa | |
| Westridge Medical Centre | |
| Durban, South Africa | |
| GVI Oncology Clinical Trial Unit | |
| Western Cape, South Africa, 7570 | |
| Turkey | |
| Erciyes University Medical Faculty | |
| Kayseri, Turkey, 38039 | |
| Ukraine | |
| Cherkassy Regional Oncology Dispensary | |
| Cherkassy, Ukraine | |
| Chernivtsi Regional Oncology Center | |
| Chernivtsi, Ukraine, 58013 | |
| Oncology and Medical Radiology Chair of Dnepropetrovsk State Medical Academy | |
| Dnepropetrovsk, Ukraine | |
| Regional Anticancer Center, Department of oncoproctology | |
| Donetsk, Ukraine | |
| Municipal Clinical Hospital #2, Proctology department | |
| Kharkiv, Ukraine | |
| Medical Centre "Mriya" | |
| Kyiv, Ukraine | |
| National Cancer Institute | |
| Kyiv, Ukraine | |
| Kyiv City Oncological Hospital, Thoracic department | |
| Kyiv, Ukraine | |
| Odessa Regional Clinical Hospital | |
| Odessa, Ukraine, 65117 | |
| Uzhgorods'ka Tsentral'na Mis'ka Klinichna Likarnya, Mis'kyy Onkologichnyy Tsentr | |
| Uzhgorod, Ukraine | |
| Vinnytsya Regional Clinical Oncological Center, Vinnytsya State Medical University | |
| Vinnytsya, Ukraine | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Edda Gomez-Panzani, M.D. | Ipsen |
More Information
No publications provided
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00774930 History of Changes |
| Other Study ID Numbers: | 2-55-52030-730, TR321, 2010-019066-92 |
| Study First Received: | October 15, 2008 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration Latvia: State Agency of Medicines Czech Republic: State Institute for Drug Control Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products India: Drugs Controller General of India Serbia and Montenegro: Agency for Drugs and Medicinal Devices South Africa: Medicines Control Council Ukraine: State Pharmacological Center - Ministry of Health Brazil: National Health Surveillance Agency Croatia: Ministry of Health and Social Care Russia: Ministry of Health of the Russian Federation Turkey: Ministry of Health |
Keywords provided by Ipsen:
|
carcinoid tumor |
Additional relevant MeSH terms:
|
Carcinoid Tumor Malignant Carcinoid Syndrome Serotonin Syndrome Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Drug Toxicity |
Poisoning Substance-Related Disorders Lanreotide Angiopeptin Somatostatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013