Microencapsulated octreotide pamoate in advanced gastrointestinal and pancreatic cancer: A phase I study

British Journal of Cancer

Volumn 78, Issue 1, 1998, Pages 14-20

  Helle, S I ^a   Geisler, J ^a   Poulsen, J P ^b   Hestdal, K ^c   Meadows, K ^d   Collins, W ^e   Tveit, K M ^b   Viste, A ^a   Holly, J M P ^d   Lonning P E ^a  

^a HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^b OSLO UNIVERSITY HOSPITAL   (Norway)

^c Novartis Pharma   (Norway)

^d BRISTOL ROYAL INFIRMARY   (United Kingdom)

^e NOVARTIS   (Switzerland)

Author keywords

Growth hormone; Insulin like growth factors; Somatostatin

Indexed keywords

C PEPTIDE; EMBONIC ACID; INSULIN; OCTREOTIDE; PROTEINASE; SOMATOMEDIN B; SOMATOMEDIN BINDING PROTEIN 3; SOMATOMEDIN C; UNCLASSIFIED DRUG;

ADULT; AGED; ALOPECIA; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; DIARRHEA; DIGESTIVE SYSTEM CANCER; FEMALE; GROWTH HORMONE BLOOD LEVEL; GROWTH HORMONE RELEASE; HUMAN; INTRAMUSCULAR DRUG ADMINISTRATION; LIVER DYSFUNCTION; MALE; MICROENCAPSULATION; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; STOMACH CARCINOMA; VERTIGO;

EID: 7144242324     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/bjc.1998.435     Document Type: Article

References (51)

1. Adrian TE, Barnes AJ, Long RG, O'Shaughnessy DJ, Brown MR, Rivier JE, Vale W, Blackburn AM and Bloom SR (1981) The effects of somatostatin analogs on secretion of growth, pancreatic, and gastrointestinal hormones in man. J Clin Endocrinol Metab 53: 675-681
2. Baumann G and Abramson EC (1983) Urinary growth hormone in man: evidence for multiple molecular forms. J Clin Endocrinol Metab 56: 305-311
3. Cascinu S, Ferro ED and Catalano G (1995) A randomised trial of octreotide vs best supportive care only in advanced gastrointestinal cancer patients refractory to chemotherapy. Br J Cancer 71: 97-101
4. Coulson VJ, Wass JAH, Abdulla AF, Cotterill AM and Holly JMP (1991) Insulin-like growth factor binding proteins (IGFBPs) in acromegaly. Growth Reg 1: 119-124
5. Cwyfan-Hughes SC, Wass JAH and Holly JMP (1993) Two site-specific radioimmunoassays which demonstrate the presence of proteolytically modified insulin-like growth factor-binding protein-3 in circulation. J Endocrinol 137: 321-328
6. Dai J, Scott CD and Baxter RC (1994) Regulation of the acid-labile subunit of the insulin-like growth factor complex in cultured rat hepatocytes. Endocrinology 135: 1066-1072
7. Davenport ML, Clemmons DR, Miles MV, Camacho-Hubner C, D'Ercole AJ and Underwood LE (1990) Regulation of serum insulin-like growth factor-1 (IGF-I) and IGF binding proteins during rat pregnancy. Endocrinology 127: 1278-1286.
8. Davies SC, Wass JAH, Ross RJM, Cotterill AM, Buchanan CR, Coulson VJ and Holly JMP (1991) The induction of a specific protease for insulin-like growth factor binding protein-3 in the circulation during severe illness. J Endocrinol 130: 469-473
9. del Pozo E, Neufeld M, Schlüter K, Tortosa E, Clarenbach P, Bieder E, Wendel L, Nüesch E, Marbach P, Cramer H and Kerp L (1986) Endocrine profile of a long-acting somatostatin derivative SMS 201-995. Study in normal volunteers following subcutaneous administration. Acta Endocrinol 111: 433-439
10. di Leo A, Ferrari L, Bajetta E, Bartoli C, Vicario G, Moglia D, Miceli R, Callegari M and Bono A (1995) Biological and clinical evaluation of Lanreotide (BIM 23014), a somatostatin analogue in the treatment of advanced breast cancer. Breast Cancer Res Treat 34: 237-244
11. Dy DY, Whitehead RH and Morris DL (1992) SMS 201.995 inhibits in vitro and in vivo growth of human colon cancer. Cancer Res 52: 917-923
12. Emermann JT, Leahy M, Gout PW and Bruchowski N (1984) Elevated growth hormone in sera from breast cancer patients. Hormon Metab Res 17: 421-424
13. Ezzat S, Ren S-G, Braunstein GD and Melmed S (1992) Octreotide stimulates insulin-like growth factor binding protein-1: a potential pituitary-independent mechanism for drug action. J Clin Endocrinol Metab 75: 1459-1463
14. Figg WD, Thibault A, Cooper MR, Reid R, Headlee D, Dawson N, Kohler DR, Reed E and Sartor O (1995) A phase I study of the somatostatin analogue somatuline in patients with metastatic hormone-refractory prostate cancer. Cancer 75: 2159-2164
15. Fredstorp L, Werner S, Bang P and Hall K (1994) Inverse correlation between insulin-like growth factor binding protein-1 and insulin in patients with acromegaly during treatment with the somatostatin analogue octreotide. Clin Endocrinology 41: 495-501
16. Friess H, Büchler M, Beglinger C, Weber A, Kunz J, Fritsch K, Dennler HJ and Beger HG (1993) Low-dose octreotide treatment is not effective in patients with advanced pancreatic cancer. Pancreas 8: 540-545
17. Frost VJ, Macaulay VM, Wass JAH and Holly JMP (1993) Proteolytic modification of insulin-like growth factor binding proteins: comparison of conditioned media from human cell lines, circulating proteases and characterized enzymes. J Endocrinol 138: 545-554
18. Frost VJ, Helle SI, Lønning PE, van der Stappen JWJ and Holly JMP (1996) Effects of treatment with megestrol acetate, aminoglutethimide or formestane on insulin-like growth factor (IGF) I and II, IGF-binding proteins (IGFBPs) and IGFBP-3 protease status in patients with advanced breast cancer. J Clin Endocrinol Metab 81: 2216-2221
19. Gargosky SE, Pham HM, Wilson KF, Liu F, Guidice LC and Rosenfeld RG (1992) Measurement and characterization of insulin-like growth factor binding protein-3 in human biological fluids: discrepancies between radioimmunoassay and ligand blotting. J Clin Endocrinol Metab 131: 3051-3060
20. Girard J and Fischer-Wasels T (1990) Measurement of urinary growth hormone. Hormon Res 33(suppl 4): 12-18
21. Guler H-P, Zapf J, Schmid C and Froesch ER (1989) Insulin-like growth factors I and II in healthy man. Estimation of half-lives and production rates. Acta Endocrinol 121: 753-758
22. Helle SI, Holly JMP, Tally M, Hall K, van der Stappen J and Lønning PE (1996) Influence of treatment with tamoxifen and change in tumour burden on the IGF-system in breast cancer patients. Int J Cancer 69: 335-339
23. Holly JMP, Biddlecombe RA, Dunger DB, Edge JA, Amiel SA, Howell R, Chard T and Rees LH (1988) Circadian variation of GH-independent IGF-binding protein in diabetes mellitus and its relationship to insulin. A new role for insulin. Clin Endocrinol 29: 667-675
24. Holly JMP, Claffey DCP, Cwyfan-Hughes SC, Frost VJ and Yateman ME (1993) Proteases acting on IGFBPs: their occurrence and physiological significance. Growth Regul 3: 88-91
25. Hossenlopp P, Seurin D, Segovia-Quinson B, Lassarre C, Hardouin S and Binoux M (1986) Analysis of serum insulin-like growth factor binding proteins using Western ligand blotting: use of the method of titration of the binding proteins in competitive binding studies. Anal Biochem 154: 138-143
26. Hourd P and Edvards R (1989) Measurement of human growth hormone in urine: development and validation of a sensitive and specific assay. J Endocrinol 121: 167-175
27. Jones JI and Clemmons DR (1995) Insulin-like growth factors and their binding proteins: biological actions. Endocrine Rev 16: 3-34
28. Jyung RW, Mustoe TA, Busby WH and Clemmons DR (1994) Increased wound-breaking strength induced by insulin-like growth factor I in combination with insulin-like growth factor binding protein 1. Surgery 115: 233-239
29. Kanety H, Madjar Y, Dagan Y, Levi J, Papa MZ, Pariente C, Goldwasser B and Karasik A (1993) Serum insulin-like growth factor-binding protein-2 (IGFBP-2) is increased and IGFBP-3 is decreased in patients with prostate cancer: correlation with serum prostate-specific antigen. J Clin Endocrinol Metab 77: 229-233
30. Klijn JGM, Hoff AM, Planting AST, Verweij J, Kok T and Lamberts SWJ (1990) Treatment of patients with metastatic pancreatic and gastrointestinal tumours with the somatostatin analogue sandostatin: a phase II study including endocrine effects. Br J Cancer 62: 627-630
31. Kupfer SR, Underwood LE, Baxter RC and Clemmons DR (1992) Enhancement of the anabolic effects of growth hormone and insulin-like growth factor I by use of both agents simultaneously. J Clin Invest 91: 391-396
32. Kutz K, Nüesch E and Rosenthaler J (1986) Pharmacokinetics of SMS 201-995 in healthy subjects. Scand J Gastroenterol 21 (suppl. 119): 65-72
33. Lamson G, Guidice LC and Rosenfeld RG (1991) A simple assay for proteolysis of IGFBP-3. J Clin Endocrinol Metab 72: 1391-1393
34. Lassarre C, Lalou C, Perin L and Binoux M (1994) Protease-induced alteration of insulin-like growth factor binding protein-3 as detected by radioimmunoassay. Agreement with ligand blotting data. Growth Regul 4: 48-55.
35. Lawrence JB, Conover CA, Haddad TC, Ingle JN, Reid JM, Ames MM, Suman VJ, Marks RS, Erlichman C and Hartmann LC (1997) Evaluation of continuous infusion suramin in metastatic breast cancer: impact of plasma levels of insulin-like growth factors (IGFs) and IGF-binding proteins. Clin Cancer Res 3: 1713-1720
36. Lønning PE, Helle SI, Johannessen DC, Adlercreutz H, Lien EA, Tally M, Ekse D, Fotsis T, Anker GB and Hall K (1995) Relations between sex hormones, sex hormone binding globulin, insulin-like growth factor-I and insulin-like growth factor binding protein-I in post-menopausal breast cancer patients. Clin Endocrinol 42: 23-30.
37. Macaulay VM (1992) Insulin-like growth factors and cancer. Br J Cancer 65: 311-320.
38. Marbach P, Briner U, Lemaire M, Schweitzer A and Terasaki T (1992) From somatostatin to Sandostatin: pharmacodynamics and pharmacokinetics. Metabolism 41 (suppl. 2): 7-10
39. Pollak MN, Polychronakos C and Guyda H (1989) Somatostatin analogue SMS 201-995 reduces serum IGH-I levels in patients with neoplasms potentially dependent on IGF-I. Anticancer Res 9: 889-892
40. Qin Y, Schally AV and Willems G (1992) Treatment of liver metastases of human colon cancers in nude mice with somatostatin analogue RC-160. Int J Cancer 52: 791-796
41. Reed MJ, Christodoulides A, Koistinen R, Säppelä M, Teale JD and Ghilchik MW (1992) The effect of endocrine therapy with medroxyprogesterone acetate, 4-hydroxyandrostenedione or tamoxifen on plasma concentrations of insulin-like growth factor (IGF)-I, IGF-II and IGFBP-I in women with advanced breast cancer. Int J Cancer 52: 208-212
42. Sara VR and Hall K (1990) Insulin-like growth factors and their binding proteins. Physiol Rev 70: 591-614
43. Savage AP, Calam J, Wood CB and Bloom SR (1987) SMS 201-995 treatment and advanced intestinal cancer: a pilot study. Aliment Pharmacol Therap 1: 133-139
44. Schally AV (1988) Oncological applications of somatostatin analogues. Cancer Res 48: 6977-6985
45. Schwander JC, Hauri C, Zapf J and Froesch ER (1983) Synthesis and secretion of insulin-like growth factor and its binding protein by the perfused rat liver: dependence on growth hormone status. Endocrinology 113: 297-305
46. Serri O, Brazeau P, Kachra Z and Posner B (1992) Octreotide inhibits insulin-like growth factor-I hepatic gene expression in the hypophysectomized rat: evidence for a direct and indirect mechanism of action. Endocrinology 130: 1816-1821
47. Smith JP, Doll D, Croitoru R, Thornton C and Perry MC (1994) Octreotide has no effect on advanced colon cancer. J Clin Gastroenterol 18: 245-247
48. Szepeshazi K, Schally AV, Cai R-Z, Radulovic S, Milovanovic S and Szoke B (1991) Inhibitory effect of bombesin/gastrin-releasing peptide antagonist RC-3095 and high dose of somatostatin analogue RC-160 on nitrosamine-induced pancreatic cancers in hamsters. Cancer Res 51: 5980-5986
49. Watson SA, Morris DL, Durrant LG, Robertson JF and Hardcastle JD (1992) Inhibition of gastrin-stimulated growth of gastrointestinal tumour cells by octreotide and the gastrin/cholecystokinin antagonists, proglumide and lorglumide. Eur J Cancer 8: 1462-1467
50. Wolthers T, Grøfte T, Flyvbjerg A, Frystyk J, Vilstrup H, Ørskov H and Foegh M (1994) Dose-dependent stimulation of insulin-like growth factor-binding protein-1 by lanreotide, a somatostatin analog. J Clin Endocrinol Metab 78: 141-144
51. Ørskov H, Wolthers T, Grøfte T, Flyvbjerg A, Vilstrup H and Hamberg O (1994) Somatostatin-stimulated insulin-like growth factor binding proiein-1 release is abolished by hyperinsulinemia. J Clin Endocrinol Metab 78: 138-140