A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer

Annals of Oncology

Volumn 15, Issue 6, 2004, Pages 955-959

  Muro, K ^a   Hamaguchi, T ^a   Ohtsu, A ^b   Boku, N ^b   Chin, K ^c   Hyodo, I ^d   Fujita, H ^e   Takiyama, W ^f   Ohtsu, T ^g  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b National Cancer Center   (Japan)

^c CANCER INSTITUTE HOSPITAL   (Japan)

^d NATIONAL HOSPITAL ORGANIZATION SHIKOKU CANCER CENTER   (Japan)

^e KURUME UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f HIROSHIMA CITY ASA HOSPITAL   (Japan)

^g Aventis Pharma Ltd   (Japan)

Author keywords

Docetaxel; Esophageal cancer; Phase II study; RECIST; Single agent

Indexed keywords

ANTIBIOTIC AGENT; ANTIEMETIC AGENT; ANTIHISTAMINIC AGENT; CISPLATIN; CORTICOSTEROID; DOCETAXEL; FLUOROURACIL; NEDAPLATIN; PLATINUM DERIVATIVE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; AGED; ANOREXIA; ARTICLE; CANCER RADIOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DISEASE SEVERITY; DOSE RESPONSE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG WITHDRAWAL; ESOPHAGUS CANCER; ESOPHAGUS RESECTION; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HISTOPATHOLOGY; HUMAN; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; MALE; METASTASIS POTENTIAL; MONOTHERAPY; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SQUAMOUS CELL CARCINOMA; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA;

EID: 3442902880     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdh231     Document Type: Article

References (28)

1. Greenlee RT, Hill-Harmon MB, Murray T et al. Cancer Statistics, 2001. CA Cancer J Clin 2001; 51: 15-36.
2. Blot WJ, McLaughlin JK. The changing epidemiology of esophageal cancer. Semin Oncol 1999; 26: 2-8.
3. Foundation for Promotion of Cancer Research. Cancer Statistics in Japan Editorial Board. Tokyo, Japan: National Cancer Center 2001.
4. National Cancer Institute. Esophageal Cancer Treatment (PDQ®): Treatment Information for Health Professionals. [On-line]. http://www.cancer.gov/cancerinfo/pdq/treatment/esophageal/ healthprofessional/(2 April 2004, date last accessed).
5. Enzinger PC, Ilson DH, Kelse DP. Chemotherapy in esophageal cancer. Semin Oncol 1999; 26: 12-20.
6. Siewert JR, Stein HJ, Sendler A et al. Esophageal cancer: clinical management. In Kelsen DP, Daly JM, Kern SE et al. (eds): Gastrointestinal Oncology: Principles and Practice. Philadelphia, PA: Lippincott Williams & Wilkins 1997; pp. 261-287.
7. Ajani JA, Ilson DH, Daugherty K et al. Activity of Taxol in patients with squamous cell carcinoma and adenocarcinoma of the esophagus. J Natl Cancer Inst 1994; 86: 1086-1091.
8. Adelstein DJ, Rice TW, Rybicki LA et al. Does paclitaxel improve the chemoradiotherapy of loco-regionally advanced esophageal cancer? A non-randomized comparison with fluorouracil-based therapy. J Clin Oncol 2000; 18: 2032-2039.
9. Conroy T, Etienne PL, Adenis A et al. Phase II trial of vinorelbine in metastatic squamous cell esophageal carcinoma. J Clin Oncol 1996; 14: 164-170.
10. Bleiberg H, Conroy T, Paillot B et al. Randomized phase II study of cisplatin and 5-FU versus cisplatin alone in advanced squamous cell esophageal cancer. Eur J Cancer 1997; 33: 1216-1220.
11. Iizuka T, Kakegawa T, Ide H et al. Phase II evaluation of cisplatin and 5-fluorouracil in advanced squamous cell carcinoma of the esophagus: a Japanese Esophageal Oncology Group Trial. Jpn J Clin Oncol 1992; 22: 172-176.
12. Hayashi K, Ando N, Watanabe H et al. Phase II evaluation of protracted infusion of cisplatin and 5-fluorouracil in advanced squamous cell carcinoma of the esophagus: a Japan Esophageal Oncology Group (JEOG) Trial (JCOG9407). Jpn J Clin Oncol 2001; 31: 419-423.
13. Ilson DH, Ajani J, Bhalla K et al. Phase II trial of paclitaxel, fluorouracil, and cisplatin in patients with advanced carcinoma of the esophagus. J Clin Oncol 1998; 16: 1826-1834.
14. Ilson DH, Saltz L, Enzinger P et al. Phase II trial of weekly irinotecan plus cisplatin in advanced esophageal cancer. J Clin Oncol 1999; 17: 3270-3275.
15. al-Sarraf M, Martz K, Herskovic A et al. Progress report of combined chemoradiotherapy versus radiotherapy alone in patients with esophageal cancer: an intergroup study. J Clin Oncol 1997; 15: 277-284.
16. Sparreboom A, van Tellingen O, Nooijen WJ, Beijnen JH. Preclinical pharmacokinetics of paclitaxel and docetaxel. Anticancer Drugs 1998; 9: 1-17.
17. Metges J, Hennequin C, Ychou M et al. Docetaxel as a second-line chemotherapy in metastatic esophageal cancer: a French study. Proc Am Soc Clin Oncol 2001; 20: 160a (Abstr 635).
18. Heath EI, Urba S, Marshall J et al. Phase II trial of docetaxel chemotherapy in patients with incurable adenocarcinoma of the esophagus. Invest New Drugs 2002; 20: 95-99.
19. Fujiwara K, Kohno I, Tanaka K et al. Phase II dose escalation: A novel approach to balancing efficacy and toxicity of anticancer agents. Anticancer Res 1999;19:639-644.
20. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205-216.
21. National Cancer Institute. National Cancer Institute Common Toxicity Criteria. [On-line]. http://ctep.info.nih.gov/reporting/index.html (2 April 2004, date last accessed).
22. Miller AB, Hogestraeten B, Staquet M et al. Reporting results of cancer treatment. Cancer 1981; 47: 207-214.
23. Kanehara S. Guidelines for the Clinical and Pathologic Studies on Carcinoma of the Esophagus, 9th edition. Tokyo, Japan: Japanese Society for Esophageal Diseases 1999.
24. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38: 143-151.
25. Einzig AI, Neuberg D, Remick SC et al. Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: the Eastern Cooperative Oncology Group (ECOG) results of the protocol E1293. Med Oncol 1996; 13: 87-93.
26. Taguchi T, Furue H, Niitani H et al. Phase I clinical trial of RP56976 (docetaxel) a new anticancer drug. Gan To Kagaku Ryoho 1994; 21: 1997-2005.
27. Extra JM, Rousseau F, Bruno R et al. Phase I and pharmacokinetic study of Taxotere (RP 56976; NSC 628503) given as a short intravenous infusion. Cancer Res 1993; 53: 1037-1042.
28. Tanigawara Y, Sasaki Y, Otsu T et al. Population pharmacokinetics of docetaxel in Japanese patients. Proc Am Soc Clin Oncol 1996; 15: 479 (Abstr 1518).