A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer

Annals of Oncology

Volumn 15, Issue 9, 2004, Pages 1344-1347

  Hong, Y S ^a   Song, S Y ^a   Lee, S I ^b   Chung, H C ^a   Choi, S H ^b   Noh, S H ^b   Park, J N ^a   Han, J Y ^a   Kang, J H ^a   Lee, K S ^a   Cho, Jae Yong ^b  

^a The Catholic University of Korea   (South Korea)

^b Yonsei University College of Medicine   (South Korea)

Author keywords

Capecitabine; Gastric cancer; Metastatic; Untreated

Indexed keywords

CAPECITABINE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; BONE MARROW SUPPRESSION; CANCER PATIENT; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DISEASE SEVERITY; DOSE RESPONSE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FEASIBILITY STUDY; FEMALE; FEVER; HAND FOOT SYNDROME; HUMAN; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; METASTASIS POTENTIAL; MONOTHERAPY; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; STOMACH CANCER; STOMACH SURGERY; TREATMENT OUTCOME;

EID: 4644271767     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdh343     Document Type: Article

References (21)

1. Central Cancer Registry. Annual Report. Korea: Central Cancer Registry; 2001.
2. Cao S, Lu K, Ishitsuka H et al. Antitumor efficacy of capecitabine against fluorouracil-sensitive and resistant tumors. Proc Am Soc Clin Oncol 1997; 16: 226a (Abstr 795).
3. Miwa M, Ura M, Nishida M et al. Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 1998; 34: 1274-1281.
4. Budman DR, Meropol NJ, Reigner B et al. Preliminary studies of a novel oral fluoropyrimidine carbamate: capecitabine. J Clin Oncol 1998; 16: 1795-1802.
5. Mackean MJ, Planting AS, Twelves C et al. Phase I and pharmacological study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol 1998; 16: 2977-2985.
6. Kondo K, Chin K, Sakamoto J et al. A multicenter phase II trial using 4-week cycles of capecitabine in advanced/metastatic gastric cancer (AGC). Proc Am Soc Clin Oncol 2003; 22: 321 (Abstr 1289).
7. Evans TR, Pentheroudakis G, Paul J et al. A phase I and pharmacokinetic study of capecitabine in combination with epirubicin and cisplatin in patients with inoperable oesophago-gastric adenocarcinoma. Ann Oncol 2002; 13: 1469-1478.
8. Blum JL, Jones SE, Buzdar AU et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1999; 17: 485-493.
9. World Health Organization (WHO). Handbook for Reporting Results of Cancer Treatment. Publication No. 48. Geneva: WHO; 1979.
10. Van Cutsem E, Hoff PM, Harper P et al. Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomized, phase III trials. Br J Cancer 2004; 90: 1190-1197.
11. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38: 143-151.
12. Karpeh MS, Kelsen DP, Tepper JE. Cancers of the gastrointestinal tract: cancer of the stomach. In De Vita VT, Heilman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology, 6th edition. Philadelphia, PA: Lippincott Williams and Wilkins; 2001.
13. Constenla M, Garcia-Arroyo R, Lorenzo I et al. Docetaxel, 5-flourouracil and leucovorin as treatment for advanced gastric cancer: results of a phase II study. Gastr Cancer 2002; 5: 142-147.
14. Cascinu S, Baldelli AM, Catalano V et al. Infusional 5-fluorouracil, cisplatin and mitomycin C in advanced gastric cancer: a low cost effective regimen. Br J Cancer 2002; 86: 213-217.
15. Van Cutsem E, Findlay M, Osterwalder B et al. Capecitabine, an oral fluoropyrimidine carbamate with substantial activity in advanced colorectal cancer: results of a randomized phase II study. J Clin Oncol 2000; 18: 1337-1345.
16. Reigner B, Blesch K, Weidekamm E. Clinical pharmacokinetics of capecitabine. Clin Pharmacokinet 2001; 40: 85-104.
17. Cassidy J, Twelves C, Van Cutsem E et al. Capecitabine Colorectal Cancer Study Group. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol 2002; 13: 566-575.
18. Payne SA. A study of quality of life in cancer patients receiving palliative chemotherapy. Soc Sci Med 1992; 35: 1505-1509.
19. Liu G, Franssen E, Fitch MI et al. Patient preference for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997; 15: 110-115.
20. Borner MM, Schoffski P, de Wit R et al. Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer 2002; 38: 349-358.
21. Tebbutt N, Norman A, Cunningham D et al. Randomised, multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advance esophago-gastric cancer; interim analysis. Proc Am Soc Clin Oncol 2002; 21: 131a (Abstract 523).