Hyaluronan-Irinotecan improves progression-free survival in 5-fluorouracil refractory patients with metastatic colorectal cancer: A randomized phase II trial

Cancer Chemotherapy and Pharmacology

Volumn 67, Issue 1, 2011, Pages 153-163

  Gibbs, Peter ^a   Clingan, Philip R ^b   Ganju, Vinod ^c   Strickland, Andrew H ^d   Wong, Shirley S ^e   Tebbutt, Niall C ^f   Underhill, Craig R ^g   Fox, Richard M ^a   Clavant, Steven P ^h   Leung, Jenny ^h   Pho, Minh ^h   Brown, Tracey J ^h,i  

^a ROYAL MELBOURNE HOSPITAL   (Australia)

^b UNIVERSITY OF NEW SOUTH WALES   (Australia)

^c FRANKSTON HOSPITAL   (Australia)

^d MONASH MEDICAL CENTRE   (Australia)

^e Western General Hospital   (Australia)

^f AUSTIN HEALTH   (Australia)

^g Border Medical Oncology Australia   (Australia)

^h MONASH UNIVERSITY   (Australia)

ⁱ Alchemia Oncology Limited   (Australia)

Author keywords

CD44; Clinical trial; Colorectal cancer; Excipient; Hyaluronic acid; Irinotecan

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; 7 ETHYL 10 HYDROXYCAMPTOTHECIN GLUCURONIDE; FLUOROURACIL; GLUCURONOSYLTRANSFERASE 1A1; GLUCURONOSYLTRANSFERASE 1A6; GLUCURONOSYLTRANSFERASE 1A7; GLUCURONOSYLTRANSFERASE 1A9; HYALURONIC ACID; IRINOTECAN;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; COLORECTAL CANCER; CONSTIPATION; DIARRHEA; DISTRIBUTION VOLUME; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG GLUCURONIDATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSPNEA; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LEUKOPENIA; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PATIENT COMPLIANCE; PHARMACOGENOMICS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PULMONARY HYPERTENSION; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DIARRHEA; DISEASE-FREE SURVIVAL; DRUG CARRIERS; FEMALE; HUMANS; HYALURONIC ACID; MALE; MIDDLE AGED; NEOPLASM METASTASIS; RISK FACTORS; SURVIVAL; TREATMENT OUTCOME;

EID: 78651074702     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-010-1303-3     Document Type: Article

References (40)

1. CS Fuchs MR Moore G Harker L Villa D Rinaldi JR Hecht 2003 Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer J Clin Oncol 21 807 814 1:CAS:528: DC%2BD2cXpsVGru7k%3D 10.1200/JCO.2003.08.058 12610178 (Pubitemid 46606439)
2. JE Scott C Cummings A Brass Y Chen 1991 Secondary and tertiary structures of hyaluronan in aqueous solution, investigated by rotary shadowing-electron microscopy and computer simulation. Hyaluronan is a very efficient network-forming polymer Biochem J 274 Pt 3 699 705 1:CAS:528:DyaK3MXhvVSktrk%3D 2012600
3. JE Scott F Heatley 1999 Hyaluronan forms specific stable tertiary structures in aqueous solution: a 13C NMR study Proc Natl Acad Sci USA 96 4850 4855 1:CAS:528:DyaK1MXjtVKms7w%3D 10.1073/pnas.96.9.4850 10220382 (Pubitemid 29214500)
4. T Asplund P Heldin 1994 Hyaluronan receptors are expressed on human malignant mesothelioma cells but not on normal mesothelial cells Cancer Res 54 4516 4523 1:CAS:528:DyaK2cXltlWhsbg%3D 7519123
5. D Naor RV Sionov D Ish-Shalom 1997 CD44: structure, function, and association with the malignant process Adv Cancer Res 71 241 319 1:CAS:528:DyaK2sXjvVOkurs%3D 10.1016/S0065-230X(08)60101-3 9111868
6. P Auvinen R Tammi M Tammi R Johansson VM Kosma 2005 Expression of CD 44 s, CD 44 v 3 and CD 44 v 6 in benign and malignant breast lesions: correlation and colocalization with hyaluronan Histopathology 47 420 428 1:STN:280:DC%2BD2MrgslWjsw%3D%3D 10.1111/j.1365-2559.2005.02220.x 16178897 (Pubitemid 41428491)
7. G Makrydimas N Zagorianakou P Zagorianakou NJ Agnantis 2003 CD44 family and gynaecological cancer In Vivo 17 633 640 1:CAS:528:DC%2BD2cXht1Cjs7Y%3D 14758731
8. M Culty M Shizari EW Thompson CB Underhill 1994 Binding and degradation of hyaluronan by human breast cancer cell lines expressing different forms of CD44: correlation with invasive potential J Cell Physiol 160 275 286 1:CAS:528:DyaK2cXltlWrurs%3D 10.1002/jcp.1041600209 7518822 (Pubitemid 24259562)
9. Brown TJ, Falzon J, Pho M, Hatherell E, Vaghela V, Wilson J, Fox R, Gibbs P, Rosenthal M, Fraser J, Brownlee G (2005) The development of hyaluronic acid as a targeted transport vehicle for chemotherapeutic drugs. In: Balazs EA, Hascall VC (eds) Hyaluronan: structure, metabolism, biological activities. therapeutic applications, Edition. Matrix Biology Institute, New Jersey, pp 421-433
10. P Gibbs TJ Brown R Ng R Jennens E Cinc M Pho M Michael RM Fox 2008 A pilot human evaluation of a formulation of irinotecan and hyaluronic acid in 5-Fluorouracil metastatic colorectal cancer patients Chemotherapy 55 49 59 10.1159/000180339 19060478
11. MA Rosenthal P Gibbs TJ Brown S Wong S Uren A Ellis L Li P Heldin H Poliviou RM Fox 2005 Phase I and pharmacokinetic evaluation of intravenous hyaluronic acid in combination with doxorubicin or 5-fluorouracil Chemotherapy 51 132 141 1:CAS:528:DC%2BD2MXkvVOgu70%3D 10.1159/000085621 15886473 (Pubitemid 40981071)
12. D Cunningham S Pyrhönen RD James CJ Punt TF Hickish R Heikkila TB Johannesen H Starkhammar CA Topham L Awad C Jacques P Herait 1998 Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer Lancet 352 1413 1418 1:CAS:528:DyaK1cXnsVSmsLs%3D 10.1016/S0140-6736(98)02309-5 9807987 (Pubitemid 28510874)
13. P Rougier E Van Cutsem E Bajetta N Niederle K Possinger R Labianca M Navarro R Morant H Bleiberg J Wils L Awad P Herait C Jacques 1998 Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer Lancet 352 1407 1412 1:CAS:528:DyaK1cXnsVSmsLo%3D 10.1016/S0140-6736(98)03085-2 9807986 (Pubitemid 28510873)
14. P Rougier R Bugat JY Douillard S Culine E Suc P Brunet Y Becouarn M Ychou M Marty JM Extra J Bonneterre A Adenis JF Seitz G Ganem M Namer T Conroy S Negrier Y Merrouche F Burki M Mousseau P Herait M Mahjoubi 1997 Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy J Clin Oncol 15 251 260 1:CAS:528:DyaK2sXnsV2msw%3D%3D 8996150
15. N Tsavaris N Ziras C Kosmas T Giannakakis P Gouveris M Vadiaka A Dimitrakopoulos D Karadima S Rokana E Papalambros G Papastratis H Margaris H Tsipras A Polyzos 2003 Two different schedules of irinotecan (CPT-11) in patients with advanced colorectal carcinoma relapsing after a 5-fluorouracil and leucovorin combination. A randomized study Cancer Chemother Pharmacol 52 514 519 1:CAS:528:DC%2BD3sXovVKntbg%3D 10.1007/s00280-003-0659-z 14504920 (Pubitemid 37491643)
16. E Van Cutsem D Cunningham WW Ten Bokkel Huinink CJ Punt CG Alexopoulos L Dirix M Symann GH Blijham P Cholet G Fillet C Van Groeningen JM Vannetzel F Levi G Panagos C Unger J Wils C Cote C Blanc P Hérait H Bleiberg 1999 Clinical activity and benefit of irinotecan (CPT-11) in patients with colorectal cancer truly resistant to 5-fluorouracil (5-FU) Eur J Cancer 35 54 59 10.1016/S0959-8049(98)00353-0 10211088 (Pubitemid 29079491)
17. HC Pitot RM Goldberg JM Reid JA Sloan PA Skaff C Erlichman J Rubin PA Burch AA Adjei SA Alberts LJ Schaaf G Elfring LL Miller 2000 Phase I dose-finding and pharmacokinetic trial of irinotecan hydrochloride (CPT-11) using a once-every-three-week dosing schedule for patients with advanced solid tumor malignancy Clin Cancer Res 6 2236 2244 1:CAS:528:DC%2BD3cXksVGhsrY%3D 10873073
18. P Therasse SG Arbuck EA Eisenhauer J Wanders RS Kaplan L Rubinstein J Verweij M Van Glabbeke AT van Oosterom MC Christian SG Gwyther 2000 New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada J Natl Cancer Inst 92 205 216 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10.1093/jnci/92.3.205 10655437
19. R Mick E Gupta EE Vokes MJ Ratain 1996 Limited-sampling models for irinotecan pharmacokinetics-pharmacodynamics: prediction of biliary index and intestinal toxicity J Clin Oncol 14 2012 2019 1:CAS:528:DyaK28XksFejtrc%3D 8683231
20. E Rouits M Boisdron-Celle A Dumont O Guérin A Morel E Gamelin 2004 Relevance of different UGT1A1 polymorphisms in irinotecan-induced toxicity: a molecular and clinical study of 75 patients Clin Cancer Res 10 5151 5159 1:CAS:528:DC%2BD2cXmtlSitbs%3D 10.1158/1078-0432.CCR-03-0548 15297419 (Pubitemid 39099790)
21. H Yamanaka M Nakajima M Katoh Y Hara O Tachibana J Yamashita HL McLeod T Yokoi 2004 A novel polymorphism in the promoter region of human UGT1A9 gene (UGT1A9*22) and its effects on the transcriptional activity Pharmacogenetics 14 329 332 1:CAS:528:DC%2BD2cXltVartr0%3D 10.1097/00008571- 200405000-00008 15115919 (Pubitemid 38638920)
22. SS Thomas SS Li JW Lampe JD Potter J Bigler 2006 Genetic variability, haplotypes, and htSNPs for exons 1 at the human UGT1A locus Hum Mutat 27 717 731 10.1002/humu.9432 16786511
23. JRE Fraser AU Engström-Laurent GB Laurent 1984 Elimination of hyaluronic acid from the blood stream in the human Clin Exp Pharmacol Physiol 11 17 25 1:CAS:528:DyaL2cXhsFSlsrk%3D 10.1111/j.1440-1681.1984.tb00235.x 6713733
24. AF Sobrero J Maurel L Fehrenbacher W Scheithauer YA Abubakr MP Lutz ME Vega-Villegas C Eng EU Steinhauer J Prausova HJ Lenz C Borg G Middleton H Kröning G Luppi O Kisker A Zubel C Langer J Kopit HA Burris 3rd 2008 EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer J Clin Oncol 26 2311 2319 1:CAS:528:DC%2BD1cXntVOltrk%3D 10.1200/JCO.2007.13.1193 18390971
25. C Tournigand A de Gramont 2006 Reflexion on a good strategy of use of oxaliplatine with 5-fluorouracil and its derivatives in patients with advanced colorectal cancer Bull Cancer 93 Suppl 1 S11 S15 1:CAS:528:DC%2BD28XkvVSlsrY%3D 16483941
26. Di Fiore F, Van Cutsem E, Laurent-Puig P, Siena S, Frattini M, De Roock W, Lièvre A, Sartore-Bianchi A, Bardelli A, Tejpar S (2008) Role of KRAS mutation in predicting response, progression-free survival, and overall survival in irinotecan-refractory patients treated with cetuximab plus irinotecan for a metastatic colorectal cancer: analysis of 281 individual data from published series. J Clin Oncol 26 (May 20 suppl; abstr 4035)
27. W De Roock H Piessevaux J De Schutter M Janssens G De Hertogh N Personeni B Biesmans JL Van Laethem M Peeters Y Humblet E Van Cutsem S Tejpar 2008 KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab Ann Oncol 19 508 515 10.1093/annonc/mdm496 17998284 (Pubitemid 351325672)
28. A Jimeno WA Messersmith FR Hirsch WA Franklin SG Eckhardt 2009 KRAS mutations and sensitivity to epidermal growth factor receptor inhibitors in colorectal cancer: practical application of patient selection J Clin Oncol 27 1130 1136 1:CAS:528:DC%2BD1MXktVCisro%3D 10.1200/JCO.2008.19.8168 19124802
29. NE Schoemaker IE Kuppens V Moiseyenko B Glimelius M Kjaer H Starkhammer DJ Richel R Smaaland K Bertelsen JP Poulsen E Voznyi J Norum D Fennelly KM Tveit A Garin G Gruia A Mourier D Sibaud P Lefebvre JH Beijnen JH Schellens WW ten Bokkel Huinink 2004 A randomized phase II multicentre trial of irinotecan (CPT-11) using four different schedules in patients with metastatic colorectal cancer Br J Cancer 91 1434 1441 1:CAS:528:DC%2BD2cXotlCktbY%3D 15381932
30. RH Mathijssen J Verweij WJ Loos P de Bruijn K Nooter A Sparreboom 2002 Irinotecan pharmacokinetics-pharmacodynamics: the clinical relevance of prolonged exposure to SN-38 Br J Cancer 87 144 150 1:CAS:528: DC%2BD38XltFeksL0%3D 10.1038/sj.bjc.6600447 12107833
31. E Van Cutsem L Dirix JL Van Laethem S Van Belle M Borner M Gonzalez Baron A Roth R Morant E Joosens G Gruia D Sibaud H Bleiberg 2005 Optimisation of irinotecan dose in the treatment of patients with metastatic colorectal cancer after 5-FU failure: results from a multinational, randomised phase II study Br J Cancer 92 1055 1062 10.1038/sj.bjc.6602462 15756271 (Pubitemid 40546669)
32. RH Mathijssen A Sparreboom H Dumez AT van Oosterom EA de Bruijn 2002 Altered irinotecan metabolism in a patient receiving phenytoin Anticancer Drugs 13 139 140 1:CAS:528:DC%2BD38XisVWrtLc%3D 10.1097/00001813-200202000-00004 11901305 (Pubitemid 34183642)
33. P Canal C Gay A Dezeuze JY Douillard R Bugat R Brunet A Adenis P Herait F Lokiec A Mathieu-Boue 1996 Pharmacokinetics and pharmacodynamics of irinotecan during a phase II clinical trial in colorectal cancer. Pharmacology and Molecular Mechanisms Group of the European Organization for Research and Treatment of Cancer J Clin Oncol 14 2688 2695 1:CAS:528:DyaK28XmsFCgtrk%3D 8874328
34. DF Kehrer W Yamamoto J Verweij MJ de Jonge P de Bruijn A Sparreboom 2000 Factors involved in prolongation of the terminal disposition phase of SN-38: clinical and experimental studies Clin Cancer Res 6 3451 3458 1:CAS:528:DC%2BD3cXntFCisrY%3D 10999728
35. A Sparreboom DF Kehrer RH Mathijssen R Xie MJ de Jonge P de Bruijn AS Planting FA Eskens C Verheij G de Heus A Klaren S Zhang T Verhaeghe PA Palmer J Verweij 2004 Phase I and pharmacokinetic study of irinotecan in combination with R115777, a farnesyl protein transferase inhibitor Br J Cancer 90 1508 1515 1:CAS:528:DC%2BD2cXjtVWkt7Y%3D 10.1038/sj.bjc.6601732 15083177 (Pubitemid 38648230)
36. PJ Tobin P Beale L Noney S Liddell LP Rivory S Clarke 2006 A pilot study on the safety of combining chrysin, a non-absorbable inducer of UGT1A1, and irinotecan (CPT-11) to treat metastatic colorectal cancer Cancer Chemother Pharmacol 57 309 316 1:CAS:528:DC%2BD28XislWkurk%3D 10.1007/s00280-005-0053-0 16003560
37. P Tobin S Clarke JP Seale S Lee M Solomon S Aulds M Crawford J Gallagher T Eyers L Rivory 2006 The in vitro metabolism of irinotecan (CPT-11) by carboxylesterase and beta-glucuronidase in human colorectal tumours Br J Clin Pharmacol 62 122 129 1:CAS:528:DC%2BD28XoslKnsLw%3D 10.1111/j.1365-2125.2005. 02477.x 16842384
38. G Allegrini A Di Paolo E Cerri S Cupini F Amatori G Masi R Danesi L Marcucci G Bocci M Del Tacca A Falcone 2006 Irinotecan in combination with thalidomide in patients with advanced solid tumors: a clinical study with pharmacodynamic and pharmacokinetic evaluation Cancer Chemother Pharmacol 58 585 593 1:CAS:528:DC%2BD28Xns1Smsbk%3D 10.1007/s00280-006-0205-x 16680463 (Pubitemid 44167383)
39. R Xie RH Mathijssen A Sparreboom J Verweij MO Karlsson 2002 Clinical pharmacokinetics of irinotecan and its metabolites: a population analysis J Clin Oncol 20 3293 3301 1:CAS:528:DC%2BD38XmsF2rs7w%3D 10.1200/JCO.2002.11.073 12149304 (Pubitemid 34835675)
40. DF Kehrer A Sparreboom J Verweij P de Bruijn CA Nierop J van de Schraaf EJ Ruijgrok MJ de Jonge 2001 Modulation of irinotecan-induced diarrhea by co treatment with neomycin in cancer patients Clin Cancer Res 7 1136 1141 1:CAS:528:DC%2BD3MXktlemurY%3D 11350876