Phase i trial of weekly cisplatin, irinotecan and paclitaxel in patients with advanced gastrointestinal cancer

Investigational New Drugs

Volumn 27, Issue 4, 2009, Pages 366-373

  Tew, William P ^a   Radovich, Delia ^a   O'Reilly, Eileen ^a   Schwartz, Gary ^a   Schrag, Deborah ^a   Saltz, Leonard B ^a   Kelsen, David P ^a   Kepler, Stacey ^a   Ilson, David H ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Cisplatin; Gastrointestinal cancer; Irinotecan; Paclitaxel; Phase I

Indexed keywords

ATROPINE; CIMETIDINE; CISPLATIN; DEXAMETHASONE; DIPHENHYDRAMINE; ERYTHROPOIETIN; GRANISETRON; GRANULOCYTE COLONY STIMULATING FACTOR; IRINOTECAN; LOPERAMIDE; PACLITAXEL; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ABDOMINAL CRAMP; ADULT; ADVANCED CANCER; AGED; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ARTIFICIAL HEART PACEMAKER; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; DEHYDRATION; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG MECHANISM; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ESOPHAGEAL ADENOCARCINOMA; ESOPHAGEAL SQUAMOUS CELL CARCINOMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPONATREMIA; LIVER CELL CARCINOMA; MALE; MAXIMUM TOLERATED DOSE; METASTASIS; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PANCREAS ADENOCARCINOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SINGLE DRUG DOSE; SINUS BRADYCARDIA; STOMACH ADENOCARCINOMA; STOMACH OBSTRUCTION; SYNCOPE; THROMBOCYTOPENIA; TREATMENT RESPONSE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CISPLATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GASTROINTESTINAL NEOPLASMS; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM METASTASIS; NEUTROPENIA; PACLITAXEL;

EID: 67651154526     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-008-9194-4     Document Type: Article

References (37)

1. A Jemal R Siegel E Ward 2008 Cancer statistics, 2008 CA Cancer J Clin 58 71 96 doi:10.3322/CA.2007.0010
2. PC Enzinger RJ Mayer 2003 Esophageal cancer N Engl J Med 349 2241 2252 doi:10.1056/NEJMra035010
3. MA Shah GK Schwartz 2004 Treatment of metastatic esophagus and gastric cancer Semin Oncol 31 574 587 doi:10.1053/j.seminoncol.2004.04.013
4. H Bleiberg T Conroy B Paillot 1997 Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer Eur J Cancer 33 1216 1220 doi:10.1016/S0959-8049(97)00088-9
5. C Barone A Cassano M Landriscina 2000 Bolus and infusional 5-fluorouracil combined with cisplatin in advanced gastric cancer Oncol Rep 7 1305 1309
6. E Van Custem V Moiseyenko S Tjulandin 2006 Phase 3 study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group J Clin Oncol 24 4991 4997 doi:10.1200/JCO.2006.06.8429
7. M Fukuda K Nishio F Kanzawa 1996 Synergism between cisplatin and topoisomerase I inhibitors, NB-506 and SN-38, in human small cell lung cancer cells Cancer Res 56 789 793
8. N Masumoto S Nakano T Esaki 1995 Sequence-dependent modulation of anticancer drug activities by 7-ethyl-10-hydroxycamptothecin in an HST-1 human squamous carcinoma cell line Anticancer Res 15 405 409
9. Y Kano K Suzuki M Akutsu 1992 Effects of CPT-11 in combination with other anti-cancer agents in culture Int J Cancer 50 604 610 doi:10.1002/ijc. 2910500420
10. K Noda Y Nishiwaki M Kawahara Japan Clinical Oncology Group 2002 Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer N Engl J Med 346 85 91 doi:10.1056/NEJMoa003034
11. N Hanna PA Bunn C Langer 2006 Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer J Clin Oncol 24 2038 2043 doi:10.1200/JCO.2005.04.8595
12. N Boku A Ohtsu Y Shimada 1999 Phase II study of a combination of irinotecan and cisplatin against metastatic gastric cancer J Clin Oncol 17 319 323 (Pubitemid 29022409)
13. K Shirao Y Shimada H Kondo 1997 Phase I-II study of irinotecan hydrochloride combined with cisplatin in patients with advanced gastric cancer J Clin Oncol 15 921 927 (Pubitemid 27106273)
14. LB Saltz D Spriggs LJ Schaaf 1998 Phase I clinical and pharmacologic study of weekly cisplatin combined with weekly irinotecan in patients with advanced solid tumors J Clin Oncol 16 3858 3865 (Pubitemid 29001539)
15. DH Ilson L Saltz P Enzinger 1999 Phase II trial of weekly irinotecan plus cisplatin in advanced esophageal cancer J Clin Oncol 17 3270 3275 (Pubitemid 29470662)
16. JA Ajani J Baker PW Pisters 2002 Irinotecan/cisplatin in advanced, treated gastric or gastroesophageal junction carcinoma Oncology (Williston Park) 16 16 18
17. JA Ajani J Baker PW Pisters 2002 CPT-11 plus cisplatin in patients with advanced, untreated gastric or gastroesophageal junction carcinoma: results of a phase II study Cancer 94 641 646 doi:10.1002/cncr.10279
18. DH Ilson M Bains DP Kelsen 2003 Phase I trial of escalating-dose irinotecan given weekly with cisplatin and concurrent radiotherapy in locally advanced esophageal cancer J Clin Oncol 21 2926 2932 doi:10.1200/JCO.2003.02.147
19. JA Ajani G Walsh R Komaki 2004 Preoperative induction of CPT-11 and cisplatin chemotherapy followed by chemoradiotherapy in patients with locoregional carcinoma of the esophagus or gastroesophageal junction Cancer 100 2347 2354 doi:10.1002/cncr.20284
20. W Tew B Minsky M Bains 2005 Phase II trial of preoperative combined modality therapy for esophageal carcinoma: induction cisplatin-irinotecan followed by concurrent cisplatin-irinotecan and radiotherapy Proc Am Soc Clin Oncol 23 4017 abst
21. JA Ajani DH Ilson K Daugherty 1994 Activity of taxol in patients with squamous cell carcinoma and adenocarcinoma of the esophagus J Natl Cancer Inst 86 1086 1091 doi:10.1093/jnci/86.14.1086 (Pubitemid 24228477)
22. DH Ilson A Forastiere M Arquette 2000 A phase II trial of paclitaxel and cisplatin in patients with advanced carcinoma of the esophagus Cancer J 6 316 323 (Pubitemid 30823304)
23. D Ilson S Wadleigh L Leichman 2007 Paclitaxel given by weekly one hour infusion in advanced esophageal cancer Ann Oncol 18 898 902 doi:10.1093/annonc/ mdm004
24. P Therasse SG Arbuck EA Eisenhauer 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 doi:10.1093/jnci/92.3. 205
25. P Ross M Nicolson D Cunningham 2002 Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer J Clin Oncol 20 1996 2004 doi:10.1200/JCO.2002.08.105
26. L Lin J Hecht 2000 A Phase II trial of irinotecan in patients with advanced adenocarcinoma of the GE junction Proc Am Soc Clin Oncol 19 1130 abstr
27. S Petrasch A Welt A Reinacher 1998 Chemotherapy with cisplatin and paclitaxel in patients with locally advanced, recurrent or metastatic oesophageal cancer Br J Cancer 78 511 514 (Pubitemid 28360641)
28. AN Gordon CA Stringer CM Matthews 1997 Phase I dose escalation of paclitaxel in patients with advanced ovarian cancer receiving cisplatin: rapid development of neurotoxicity is dose-limiting J Clin Oncol 15 1965 1973 (Pubitemid 27209527)
29. C Wasserheit A Frazein R Oratz 1996 Phase II trial of paclitaxel and cisplatin in women with advanced breast cancer: an active regimen with limiting neurotoxicity J Clin Oncol 14 1993 1999 Erratum in: J Clin Oncol 14:3175 (Pubitemid 26230099)
30. PC Enzinger J Clark D Ryan 2004 Phase II study of docetaxel, cisplatin, and irinotecan in advanced esophageal and gastric cancer Proc Am Soc Clin Oncol 22 4040 abstr
31. MA Socinski AB Sandler LL Miller 2001 Phase I trial of the combination of irinotecan, paclitaxel, and carboplatin in patients with advanced non-small-cell lung cancer J Clin Oncol 19 1078 1087 (Pubitemid 32176284)
32. MA Socinski AB Sandler VK Israel 2002 Phase II trial of irinotecan, paclitaxel and carboplatin in patients with previously untreated Stage IIIB/IV nonsmall cell lung carcinoma Cancer 95 1520 1527 doi:10.1002/cncr.10852
33. G Frasci G Nicolella P Comella 2001 A weekly regimen of cisplatin, paclitaxel and topotecan with granulocyte-colony stimulating factor support for patients with extensive disease small cell lung cancer: a phase II study Br J Cancer 84 1166 1171 doi:10.1054/bjoc.2001.1741
34. G Frasci N Panza P Comella 1999 Cisplatin-topotecan-paclitaxel weekly administration with G-CSF support for ovarian and small-cell lung cancer patients: a dose-finding study Ann Oncol 10 355 358 doi:10.1023/A:1008301222560
35. MS Gonzalez E Calvo JM Gassent 2003 Treatment of advanced non-small cell lung cancer (NSCLC) with a bi-weekly schedule of irinotecan (I), paclitaxel (T) and cisplatinum (P). A feasibility study Proc Am Soc Clin Oncol 22 2816 abstr
36. VM Herben VR Panday DJ Richel 1999 Phase I and pharmacologic study of the combination of paclitaxel, cisplatin, and topotecan administered intravenously every 21days as first-line therapy in patients with advanced ovarian cancer J Clin Oncol 17 747 755 (Pubitemid 29109301)
37. DR D'Adamo M Bains B Minsky 2003 A phase I trial of paclitaxel, cisplatin, irinotecan and concurrent radiation therapy in locally advanced esophageal cancer Proc Am Soc Clin Oncol 22 1401 abstr