An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer

British Journal of Cancer

Volumn 95, Issue 2, 2006, Pages 159-163

  Chao, Y ^a,b,c   Li, C P ^a,c   Chao, T Y ^d   Su, W C ^e   Hsieh, R K ^f   Wu, M F ^g   Yeh, K H ^h,i,j   Kao, W Y ^d   Chen, L T ^a,k,l   Cheng, A L ^h,i  

^a TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^b Central Clinic Hospital   (Taiwan)

^c NATIONAL YANG MING UNIVERSITY   (Taiwan)

^d TRI SERVICE GENERAL HOSPITAL   (Taiwan)

^e NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

^f MACKAY MEMORIAL HOSPITAL   (Taiwan)

^g CHUNG SHAN MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^h NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

ⁱ NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^j FAR EASTERN MEMORIAL HOSPITAL   (Taiwan)

^k NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

^l KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

more..

Author keywords

Gastric cancer; Leucovorin; Paclitaxel; UFT

Indexed keywords

CIMETIDINE; DEXAMETHASONE; DIPHENHYDRAMINE; FOLINIC ACID; PACLITAXEL; UFT;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; BODY WEIGHT DISORDER; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER LOCALIZATION; CANCER PATIENT; CANCER RECURRENCE; CANCER SURGERY; CARDIOTOXICITY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG INFUSION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVALUATION; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HISTOPATHOLOGY; HUMAN; HYPESTHESIA; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SAMPLE SIZE; SENSORY NEUROPATHY; SINUS TACHYCARDIA; STOMACH CANCER; STOMATITIS; SURVIVAL TIME; THERAPY EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE; WEIGHT REDUCTION;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COMBINED MODALITY THERAPY; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; PACLITAXEL; PROSPECTIVE STUDIES; SAFETY; STOMACH NEOPLASMS; SURVIVAL RATE; TEGAFUR; TREATMENT OUTCOME; URACIL;

EID: 33745960387     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6603225     Document Type: Article

References (36)

1. Ajani JA, Fairweather J, Dumas P, Patt YZ, Pazdur R, Mansfield PF (1998) Phase II study of Taxol in patients with advanced gastric carcinoma. Cancer J Sci Am 4: 269-274
2. Ajani JA, Fodor MB, Tjulandin SA, Moiseyenko VM, Chao Y, Cabral Filho S, Majlis A, Assadourian S, Van Cutsem E (2005) Phase II multi-institutional randomized trial of docetaxel plus cisplatin with or without fluorouracil in patients with untreated, advanced gastric, or gastroesophageal adenocarcinoma. J Clin Oncol 23: 5660-5667
3. Anderson N, Lokich J (1992) Controversial issues in 5-fluorouracil infusion use. Dose intensity, treatment duration, and cost comparisons. Cancer 70(Suppl): 998-1002
4. Caplow M, Shanks J, Ruhlen R (1994) How taxol modulates microtubule disassembly. J Biol Chem 269: 23399-23402
5. Chao Y, Yeh KH, Chang CJ, Chen LT, Chao TY, Wu MF, Chang CS, Chang JY, Chung CY, Kao WY, Hsieh RK, Cheng AL (2004) Phase II study of oxaliplatin and weekly 24-hour infusion of high-dose 5-fluorouracil and folinic acid in the treatment of advanced gastric cancer. Br J Cancer 90: 453-458
6. Chen LT, Liu TW, Wu CW, Chung TR, Shiah HS, Jan CM, Liu JM, Whang-Peng J, Chang JY (2002) A phase I study of weekly docetaxel, 24-hour infusion of high-dose fluorouracil/leucovorin and cisplatin in patients with advanced gastric cancer. Oncology 63: 239-247
7. Chong G, Cunningham D (2005) Gastrointestinal cancer: recent developments in medical oncology. Eur J Surg Oncol 31: 453-460
8. De Vivo R, Pignata S, Palaia R, Parisi V, Daniele B (2000) The role of chemotherapy in the management of gastric cancer. J Clin Gastroenterol 30: 364-371
9. Ho DH, Pazdur R, Covington W, Brown N, Huo YY, Lassere Y, Kuritani J (1998) Comparison of 5-fluorouracil pharmacokinetics in patients receiving continuous 5-fluorouracil infusion and oral uracil plus N1-(2′- tetrahydrofuryl)-5-fluorouracil. Clin Cancer Res 4: 2085-2088
10. Hsu CH, Yeh KH, Chen LT, Liu JM, Jan CM, Lin JT, Chen YC, Cheng AL (1997) Weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin in the treatment of advanced gastric cancers. Oncology 54: 275-280
11. Kakeji Y, Emi Y, Baba H, Tokunaga E, Oki E, Yamamoto M, Ikebe M, Maehara Y, Hashizume M (2005) Efficacy of weekly paclitaxel in patients with advanced gastric cancer: phase II study in Japan. 2005 Gastrointestinal Cancers Symposium, abstract 53
12. Kamineni P, Prakasa K, Hasan SP, Akula R, Dawkins F (2003) Cardiotoxicities of paclitaxel in African Americans. J Natl Med Assoc 95: 977-981
13. Lee KD, Liu TW, Wu CW, Tiu CM, Liu JM, Chung TR, Chang JY, Whang-Peng J, Chen LT (2002) Non-surgical treatment for afferent loop syndrome in recurrent gastric cancer complicated by peritoneal carcinomatosis: percutaneous transhepatic duodenal drainage followed by 24-hour infusion of high-dose fluorouracil and leucovorin. Ann Oncol 13: 1151-1155
14. Lin YC, Chen JS, Wang CH, Wang HM, Chang HK, Liaul CT, Yang TS, Liaw CC, Liu HE (2001) Weekly high-dose 5-fluorouracil (5-FU), leucovorin (LV) and bimonthly cisplatin in patients with advanced gastric cancer. Jpn J Clin Oncol 31: 605-609
15. Lin YC, Liu HE, Wang CH, Wang HM, Yang TS, Liau CT, Chen JS (1999) Clinical benefit and response in patients with gastric cancer to weekly 24-hour infusion of high-dose 5-fluorouracil (5-FU) and leucovorin (LV). Anticancer Res 19: 5615-5620
16. Louvet C, Andre T, Tigaud JM, Gamelin E, Douillard JY, Brunet R, Francois E, Jacob JH, Levoir D, Taamma A, Rougier P, Cvitkovic E, de Gramont A (2002) Phase II study of oxaliplatin, fluorouracil, and folinic acid in locally advanced or metastatic gastric cancer patients. J Clin Oncol 20: 4543-4548
17. Meropol NJ, Rustum YM, Petrelli NJ, Rodriguez-Bigas M, Frank C, Ho DH, Kurowski M, Creaven PJ (1996) A phase I and pharmacokinetic study of oral uracil, ftorafur, and leucovorin in patients with advanced cancer. Cancer Chemother Pharmacol 37: 581-586
18. Miller AB, Hoogstraten B, Staquet M, Winkler A (1981) Reporting results of cancer treatment. Cancer 47: 207-214
19. Ninomiya M, Kondo K, Kojima H, Matsuo K, Hirabayashi N, Nakamura S, Kawamura S, Kobayashi M, Konno H, Sakamoto J (2005) Phase II study of weekly paclitaxel plus 5-fluorouracil in patients with unresectable advanced or recurrent gastric cancer. 2005 Proceedings of the American Society of Clinical Oncology, abstract 4075
20. Ohtsu A (2005) Current status and future prospects of chemotherapy for metastatic gastric cancer: a review. Gastric Cancer 8: 95-102
21. Ohtsu A, Boku N, Tamura F, Muro K, Shimada Y, Saigenji K, Akazawa S, Kitajima M, Kanamaru R, Taguchi T (1998) An early phase II study of a 3-hour infusion of paclitaxel for advanced gastric cancer. Am J Clin Oncol 21: 416-419
22. Roder DM (2002) The epidemiology of gastric cancer. Gastric Cancer 5(Suppl 1): 5-11
23. Sadahiro S, Suzuki T, Kameya T, Iwase H, Tajima T, Makuuchi H (2001) A pharmacological study of the weekday-on/weekend-off oral UFT schedule in colorectal cancer patients. Cancer Chemother Pharmacol 47: 457-460
24. Schoffski P (2002) New drugs for treatment of gastric cancer. Ann Oncol 13(Suppl 4): 13-22
25. Simon R (1988) Optimal two-stage design for phase II clinical trials. Control Clin Trials 10: 1-10
26. Takeyoshi I, Makita F, Tanahashi Y, Iwazaki S, Nakamura S, Ogawa T, Ishikawa H, Ohya T, Kawate S, Morishita Y (2005) A phase II study of weekly paclitaxel and doxifluridine (an intermediate metabolite of capecitabine) combination chemotherapy for advanced/recurrent gastric cancer. 2005 Proceedings of the American Society of Clinical Oncology, abstract 4082
27. Takiuchi H, Ajani JA (1998) Uracil-tegafur in gastric carcinoma: a comprehensive review. J Clin Oncol 16: 2877-2885
28. Trotti A, Byhardt R, Stetz J, Gwede C, Corn B, Fu K, Gunderson L, McCormick B, Morrisintegral M, Rich T, Shipley W, Curran W (2000) Common toxicity criteria: version 2.0. An improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys 47: 13-47
29. Ueda Y, Yamagishi H, Ichikawa D, Morii J, Koizumi K, Kakihara N, Shimotsuma M, Takenaka A, Yamashita T, Kurioka H, Nishiyama M, Morita S, Nakamura K, Sakamoto J (2005) Phase I study of a combination of s-1 and weekly paclitaxel in patients with advanced or recurrent gastric cancer. Oncology 69: 261-268
30. Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JG, Piedbois P, Paillot B, Bodenstein H, Schmoll HJ, Bleiberg H, Nordlinger B, Couvreur ML, Baron B, Wils JA (2000) Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol 18: 2648-2657
31. Verdecchia A, Mariotto A, Gatta G, Bustamante-Teixeira MT, Ajiki W (2003) Comparison of stomach cancer incidence and survival in four continents. Eur J Cancer 39: 1603-1609
32. Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, Hughes M, Mansi J, Findlay M, Hill A, Oates J, Nicolson M, Hickish T, O'Brien M, Iveson T, Watson M, Underhill C, Wardley A, Meehan M (1997) Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol 15: 261-267
33. Yamada Y, Shirao K, Ohtsu A, Boku N, Hyodo I, Saitoh H, Miyata Y, Taguchi T (2001) Phase II trial of paclitaxel by three-hour infusion for advanced gastric cancer with short premedication for prophylaxis against paclitaxel-associated hypersensitivity reactions. Ann Oncol 12: 1133-1137
34. Yeh KH, Cheng AL (1998) Gastric cancer associated with acute disseminated intravascular coagulation: successful initial treatment with weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin. Br J Haematol 100: 769-772
35. Yeh KH, Cheng AL, Lin JF, Ma IF, Hsu CH, Lu YS, Chen YC (1998) Sequence-dependent synergism of paclitaxel and 5-fluorouracil in the treatment of gastric cancer: in vitro and pilot clinical studies. Ann Oncol 9(Suppl 4): 47 (abstract 225)
36. Yeh KH, Lu YS, Hsu CH, Lin JF, Hsu C, Kuo SH, Li SJ, Cheng AL (2005) Phase II study of weekly paclitaxel and 24-hour infusion of high-dose 5-fluorouracil and leucovorin in the treatment of recurrent or metastatic gastric cancer. Oncology 69: 88-95