Dose Escalation of Octreotide-LAR as First-Line Therapy in Resistant Acromegaly

NCT00461149 | Completed Phase 4

• 1 other identifier: NeuroendoUnit-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Epidemiological data indicate that patients with active acromegaly have reduced life expectancy because of cardiovascular (60%) and respiratory diseases (25%) mainly (1-10). A post-treatment GH value \<5 mU/liter (equal to \<2.5 μg/liter) and IGF-I in the normal range for age are recognized as the most predictive survival indices. Since their introduction into clinical use approximately two decades ago, somatostatin analogs have been considered a cornerstone of medical therapy for acromegaly. After 12 months of treatment with octreotide-LAR, control of GH and IGF-I excess, is achieved in 54% and 63% of unselected patients (11). The proportion of subjects achieving IGF-I normalization increases significantly with time (12). Significant tumor shrinkage has also been reported in a number of studies (13,14): an average 50% tumor decrease is achieved when the drug is used exclusively, or before surgery or radiotherapy (14). In 99 unselected newly diagnosed patients after 12 months of treatment with somatostatin analogues we reported control of GH levels in 57.6% and IGF-I levels in 45.5% and a greater than 50% tumor shrinkage in 44.4% (15). The dose of LAR in different studies ranged from 10-40 mg every 28 days (q28d): high doses are generally administered in patients who do not control GH and IGF-I excess with lower doses. As reported in the meta-analysis (11) the rate of IGF-I normalization tended to be lower as octreotide-LAR dose was raised: 90% in patients treated with 10 mg, 61% with 20 mg and 53% with 30 mg. However, some further benefit by increasing the dose of octreotide-LAR was reported in some studies (16-18). Data on dose escalation of octreotide-LAR given as first-line therapy in newly diagnosed patients with acromegaly are lacking.

Conditions

Acromegaly

Keywords

Acromegaly; GH; IGF-I; Pituitary tumors; Octreotide

Outcome Measures

Primary Outcomes (2)

• GH and IGF-I control

• tumor shrinkage

Secondary Outcomes (1)

• Glucose tolerance.

Interventions

Octreotide-LAR DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with newly diagnosed acromegaly
• age above 18 years
• no previous treatments for acromegaly

You may not qualify if:

• primary surgery
• concomitant hyperprolactinemia if requiring combined treatment with dopamine-agonist
• primary treatment with lanreotide
• treatment duration less than 24 months

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Molecular and Clinical Endocrinology and Oncology University Federico II of Naples

Naples, 80131, Italy

Location

Related Publications (25)

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• Kauppinen-Makelin R, Sane T, Reunanen A, Valimaki MJ, Niskanen L, Markkanen H, Loyttyniemi E, Ebeling T, Jaatinen P, Laine H, Nuutila P, Salmela P, Salmi J, Stenman UH, Viikari J, Voutilainen E. A nationwide survey of mortality in acromegaly. J Clin Endocrinol Metab. 2005 Jul;90(7):4081-6. doi: 10.1210/jc.2004-1381. Epub 2005 May 10.

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  PMID: 16449332 RESULT

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  PMID: 15613435 RESULT

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• Colao A, Ferone D, Marzullo P, Cappabianca P, Cirillo S, Boerlin V, Lancranjan I, Lombardi G. Long-term effects of depot long-acting somatostatin analog octreotide on hormone levels and tumor mass in acromegaly. J Clin Endocrinol Metab. 2001 Jun;86(6):2779-86. doi: 10.1210/jcem.86.6.7556.

  PMID: 11397887 RESULT

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• American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2006 Jan;29 Suppl 1:S43-8. No abstract available.

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• Colao A, Pivonello R, Auriemma RS, Galdiero M, Savastano S, Lombardi G. Beneficial effect of dose escalation of octreotide-LAR as first-line therapy in patients with acromegaly. Eur J Endocrinol. 2007 Nov;157(5):579-87. doi: 10.1530/EJE-07-0383.

  PMID: 17984237 DERIVED

MeSH Terms

Conditions

Acromegaly; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms

Study Officials

• Annamaria AL Colao, Prof.

  University Federico II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 17, 2007
• Study Start: January 1, 1995
• Study Completion: December 1, 2006
• Last Updated: April 17, 2007

Record last verified: 2007-04

Locations

IT (1)