Phase I trial using weekly administration of gemcitabine and docetaxel in patients with advanced pancreatic carcinoma

Chemotherapy

Volumn 50, Issue 6, 2004, Pages 289-296

  Meyer, F ^a   Lueck, A ^a   Hribaschek, A ^a   Lippert, H ^a   Ridwelski, K ^b  

^a UNIVERSITY HOSPITAL MAGDEBURG   (Germany)

^b Municipal Hospital   (Germany)

Author keywords

Docetaxel; Gemcitabine; Metastases; Pancreatic carcinoma; Phase I trial

Indexed keywords

DOCETAXEL; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANOREXIA; ARTICLE; BLOOD TOXICITY; BONE MARROW DISEASE; BONE MARROW SUPPRESSION; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CASE REPORT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG TOLERABILITY; EDEMA; FEMALE; FOOT DISEASE; GASTROINTESTINAL DISEASE; HAND DISEASE; HEMATOLOGIC DISEASE; HUMAN; HUMAN TISSUE; MALE; METASTASIS; NAUSEA; NEUROTOXICITY; PANCREAS CARCINOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; SENSORY DYSFUNCTION; SIDE EFFECT; STANDARDIZATION; TASTE DISORDER; TOXICITY; VOMITING; WORLD HEALTH ORGANIZATION;

AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEALTH STATUS; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PAIN MEASUREMENT; PANCREATIC NEOPLASMS; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TAXOIDS;

EID: 11244271542     PISSN: 00093157     EISSN: None     Source Type: Journal    
DOI: 10.1159/000082628     Document Type: Article

References (42)

1. Rosenberg L: Pancreatic cancer: Does octreotide offer any promise? Chemotherapy 2001;47(suppl 2):134-149.
2. Rothenberg ML, Moore MJ, Cripps MC, Andersen JS, Portenoy RK, Burris HA 3rd, Green MR, Tarassoff PG, Brown TD, Casper ES, Storniolo AM, Von Hoff DD: A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer. Ann Oncol 1996;7:347-353.
3. Burris HA, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol 1997;15:2403-2413.
4. Storniolo AM, Enas NH, Brown CA, Voi M, Rothenberg ML, Schilsky R: An Investigational New Drug Treatment Program for patients with gemcitabine. Cancer 1999;85:1261-1262.
5. Pohlmann BK: Neue Zytostatika: 1. Gemcitabin bei soliden Tumoren - Kombinationspartner mit guter Verträglichkeit. Dtsch Aerztebl 1996;93:B-749.
6. Lin MH, Chen JS, Chen HH, Su W: A phase II trial of gemcitabine in the treatment of advanced duct and periampullary carcinomas. Chemotherapy 2003;49:154-158.
7. Rougier P, De Forni M, Adenis A: Phase II study of Taxotere in pancreatic cancer. Proc Am Soc Clin Oncol 1994;13:200-205.
8. Casper ES, Green MR, Kelsen DP, Heelan RT, Brown TD, Flombaum CD, Trochanowski B, Tarassoff PG: Phase II trial of gemcitabine (2,2′)- difluorodeoxycytidine) in patients with adenocarcinoma of the pancreas. Invest New Drugs 1994;12:29-34.
9. Carmichael J: Clinical response benefit in patients with advanced pancreatic cancer. ESPAC Satellite Study. Digestion 1997;58:503-507.
10. Pollera CF, Ceribelli A, Crecco M, Calabresi F: Weekly gemcitabine in advanced bladder cancer: A preliminary report from a phase I study. Ann Oncol 1994;5:182-184.
11. Carmichael J, Possinger K, Phillip P, Beykirch M, Kerr H, Walling J, Harris AL: Advanced breast cancer: A phase II trial with gemcitabine. J Clin Oncol 1995;13:2731-2736.
12. Frasci G, Panza N, Comella P, Nicolella GP, Natale M, Manzione L, Bilancia D, Cioffi R, Maiorino L, De Cataldis G, Belli M, Micillo E, Mascia V, Massidda B, Lorusso V, De Lena M, Carpagnano F, Contu A, Pusceddu G, Comella G: Cisplatin, gemcitabine, and paclitaxel in locally advanced or metastatic non-small-cell lung cancer: A phase I-II study, Southern Italy Cooperative Oncology Group. J Clin Oncol 1999;17:2316-2325.
13. Giaccone G: Gemcitabine plus taxane combinations in non-small cell lung cancer. Semin Oncol 1999;26(suppl 4):19-24.
14. Hainsworth JD, Burris HA 3rd, Erland JB, Morrissey LH, Meluch AA, Kalman LA, Hon JK, Scullin DC Jr, Smith SW, Greco FA: Phase I/II trial of paclitaxel by 1-hour infusion, carboplatin, and gemcitabine in the treatment of patients with advanced nonsmall cell lung carcinoma. Cancer 1999;85:1269-1276.
15. Rizvi NA, Spiridonidis CH, Davis TH, Bhargava P, Marshall JL, Dahut W, Figuera M, Hawkins MJ: Docetaxel and gemcitabine combinations in non-small cell lung cancer. Semin Oncol 1999;26(suppl 16):27-31; discussion 41-42.
16. Dodd PM, McCaffrey JA, Hilton S, Mazumdar M, Herr H, Kelly WK, Icasiano E, Boyle MG, Bajorin DF: Phase I evaluation of sequential doxorubicin gemcitabine then ifosfamide paclitaxel cisplatin for patients with unresectable or metastatic transitional-cell carcinoma of the urothelial tract. J Clin Oncol 2000;18:840-846.
17. Pignata S, Varriale E, Casella G, Iodice F, De Placido G, Perrone F, Tramontana F, Ricchi P, De Vivo R, Costanzo R, Vernaglia A, Tramontana S: A phase I study of gemcitabine and epirubicin for the treatment of platinum-resistant or refractory advanced ovarian cancer. Ann Oncol 2000;11:613-616.
18. van Putten JW, Eppinga P, Erjavec Z, de Leede G, Nabers J, Smeets JB, Th Sleijfer D, Groen HJ: Activity of high-dose epirubicin combined with gemcitabine in advanced non-small-cell lung cancer: A multicenter phase I and II study. Br J Cancer 2000;82:806-811.
19. Delord JP, Raymond E, Chaouche M, Ruffie P, Ducreux M, Faivre S, Boige V, Le Chevalier T, Rixe O, Baudin E, Pautier P, Rodier JM, Chouaki N, Escudier B, Kayitalire L, Armand JP: A dose-finding study of gemcitabine and vinorelbine in previously treated malignancies. Ann Oncol 2000;11:73-79.
20. Frasci G, Panza N, Comella P, Nicolella GP, Natale M, Pacilio C, Gravina A, Caputi V, Botti G, Comella G: Cisplatin, gemcitabine and vinorelbine in locally advanced or metastatic non-small-cell lung cancer: A phase I study. Ann Oncol 1997;8:1045-1048.
21. Lorusso V, Carpagnano F, Frasci G, Panza N, Di Rienzo G, Cisternino ML, Napoli G, Orlando S, Cinieri S, Brunetti C, Palazzo S, De Lena M: Phase I/II study of gemcitabine plus vinorelbine as first-line chemotherapy of non-small-cell lung cancer. J Clin Oncol 2000;18:405-411.
22. Philip PA, Ibrahim D, Zalipski M: Gemcitabine and UFT plus oral calcium folinate: phase I study. Oncology (Huntingt) 1999;13(suppl 3):116-119.
23. Adjei AA, Erlichmann C: A phase I trial of MTA and gemcitabine in patients with locally advanced or metastatic cancer. Semin Oncol 1999;26(suppl 6):94-98.
24. Adjei AA, Erlichman C, Sloan JA, Reid JM, Pitot HC, Goldberg RM, Peethambaram P, Atherton P, Hanson LJ, Alberts SR, Jett J: Phase I and pharmacologic study of sequences of gemcitabine and the multitargeted antifolate agent in patients with advanced solid tumors. J Clin Oncol 2000;18:1748-1757.
25. Hidalgo M, Castellano D, Paz-Ares L, Gravalos C, Diaz-Puente M, Hitt R, Alonso S, Cortes-Funes H: Phase I-II study of gemcitabine and fluorouracil as a continuous infusion in patients with pancreatic cancer. J Clin Oncol 1999;17:585-592.
26. Oettle H, Pelzer U, Hochmuth K, Diebold T, Langrehr J, Schmidt CA, Arning M, Vogl TJ, Neuhaus P, Huhn D, Riess H: Phase I trial of gemcitabine (Gemzar), 24 h infusion 5-fluorouracil and folinic acid in patients with inoperable pancreatic cancer. Anticancer Drugs 1999;10:699-704.
27. Rothenberg ML, Sharma A, Weiss GR, Villalona-Calero MA, Eckardt JR, Aylesworth C, Kraynak MA, Rinaldi DA, Rodriguez GI, Burris HA 3rd, Eckhardt SG, Stephens CD, Forral K, Nicol SJ, Von Hoff DD: Phase I trial of paclitaxel and gemcitabine administered every two weeks in patients with refractory solid tumors. Ann Oncol 1998;9:733-738.
28. Pazdur R, Newman RA, Newman BM: Phase I trial of Taxotere: Five-day schedule. J Natl Cancer Inst 1992;84:1781-1788.
29. Tomiak E, Piccart M, Kerger J, Lips S, Awada A, de Valeriola D, Ravoet C, Lossignol D, Sculier JP, Auzannet V: Phase I study of docetaxel administered as a 1-hour intravenous infusion on a weekly basis. J Clin Oncol 1994;12:1458-1467.
30. Hainsworth JD, Burris HA, Erland JB: Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer. J Clin Oncol 1998;16:2164-2168.
31. Löffler TM, Freund W, Dörge C: Activity of weekly Taxotere (TXT) in patients with metastatic breast cancer (abstract). Proc Am Soc Clin Oncol 1998;17:113a.
32. Lück HJ, Donne S, Glaubitz M: Phase I study of weekly docetaxel (Taxotere) in heavily pretreated breast cancer patients. Eur J Cancer 1997;33:703-704.
33. Kroep JR, Peters GJ, van Moorsel CJ, Catik A, Vermorken JB, Pinedo HM, van Groeningen CJ: Gemcitabine-cisplatin: A schedule finding study. Ann Oncol 1999;10:1503-1510.
34. Mavroudis D, Kourousis C, Kakolyris S, Agelaki S, Kalbakis K, Androulakis N, Souglakos J, Vardakis N, Samonis G, Georgoulias V: Phase I study of the gemcitabine/oxaliplatin combination in patients with advanced solid tumors: A preliminary report. Semin Oncol 2000;27(suppl 2):25-30.
35. Rizvi NA: Docetaxel (Taxotere) and gemcitabine in combination therapy. Semin Oncol 1999;26(suppl 11):19-22.
36. Sherman WH, Fine RL: Combination gemcitabine and docetaxel therapy in advanced adenocarcinoma of the pancreas. Oncology 2001;60:316-320.
37. Ryan DP, Kulke MH, Fuchs CS, Grossbard ML, Grossman SR, Morgan JA, Earle CC, Shivdasani R, Kim H, Mayer RJ, Clark JW: A phase II study of gemcitabine and docetaxel in patients with metastatic pancreatic carcinoma. Cancer 2002;94:97-103.
38. Spiridonidis CH, Laufman LR, Jones J, Rhodes VA, Wallace K, Nicol S: Phase I study of docetaxel dose escalation in combination with fixed weekly gemcitabine in patients with advanced malignancies. J Clin Oncol 1998;16:3866-3873.
39. Cascinu S, Gasparini G, Catalano V, Silva RR, Pancera G, Morabito A, Giordani P, Gattuso D, Catalano G: A phase I-II study of gemcitabine and docetaxel in advanced pancreatic cancer: A report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD). Ann Oncol 1999;10:1377-1379.
40. Rischin D, Boyer M, Smith J, Millward M, Michael M, Bishop J, Zalcberg J, Davison J, Emmett E, McClure B: A phase I trial of docetaxel and gemcitabine in patients with advanced cancer. Ann Oncol 2000;11:421-426.
41. Ryan DP, Lynch TJ, Grossbard ML, Seiden MV, Fuchs CS, Grenon N, Baccala P, Berg D, Finkelstein D, Mayer RJ, Clark JW: A phase I study of gemcitabine and docetaxel in patients with metastatic solid tumors. Cancer 2000;88:180-185.
42. Ridwelski K, Lueck A, Lippert H: Phase I study of a treatment with gemcitabine and docetaxel weekly in advanced pancreatic cancer (abstract 1411). Proc 17th Int Cancer Congr (UICC) 1998, p 330.