Phase II trial of docetaxel-irinotecan combination in advanced esophageal cancer

Annals of Oncology

Volumn 20, Issue 7, 2009, Pages 1242-1248

  Burtness, Barbara ^a   Gibson, M ^b   Egleston, B ^a   Mehra, R ^a   Thomas, L ^c   Sipples, R ^d   Quintanilla, M ^d   Lacy, J ^d   Watkins, S ^e   Murren, J R ^d   Forastiere, A A ^f  

^a FOX CHASE CANCER CENTER   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^c YALE CANCER CENTER   (United States)

^d YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e ANNE ARUNDEL MEDICAL CENTER   (United States)

^f JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Chemotherapy; Docetaxel; Esophageal cancer; Irinotecan

Indexed keywords

DEXAMETHASONE; DOCETAXEL; IRINOTECAN; SEROTONIN 3 ANTAGONIST;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; DEEP VEIN THROMBOSIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; ESOPHAGEAL ADENOCARCINOMA; ESOPHAGEAL SQUAMOUS CELL CARCINOMA; ESOPHAGUS CANCER; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; HYPOPHOSPHATEMIA; LEUKOCYTE COUNT; LIVER TOXICITY; LUNG EMBOLISM; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; SYNCOPE; THROMBOSIS; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VOMITING;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CARCINOMA, SQUAMOUS CELL; DISEASE PROGRESSION; DRUG ADMINISTRATION SCHEDULE; ESOPHAGEAL NEOPLASMS; FEMALE; HUMANS; MALE; MIDDLE AGED; SURVIVAL ANALYSIS; TAXOIDS; TREATMENT OUTCOME;

EID: 67650388521     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdn787     Document Type: Article

References (33)

1. Cancer Statistics. American Cancer Society 2008 www.cancer.org/docroot/ stt/stt_0.asp (12 October 2008, date last accessed).
2. Karim-Kosa HE, de Vriesa E, Soerjomatarama I et al. Recent trends of cancer in Europe: A combined approach of incidence, survival and mortality for 17 cancer sites since the 1990s. Eur J Cancer 2008; 44: 1345-1389.
3. Bleiberg H, Conroy T, Paillot B et al. Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell esophageal cancer. Eur J Cancer 1997; 33: 1216-1220.
4. Mooney MM. Neoadjuvant and adjuvant chemotherapy for esophageal adenocarcinoma. J Surg Oncol 2005; 92: 230-238.
5. Riou JF, Naudin A, Lavelle F. Effects of Taxotere on murine and human tumor cell lines. Biochem Biophys Res Commun 1992; 187: 164-170.
6. Ajani JA, Fodor MB, Tjulandin SA et al. 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 2005; 23: 5660-5667.
7. Van Cutsem E, Moiseyenko VM, Tjulandin S et al. Phase III 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 2006; 24: 4991-4997.
8. Ajani JA, Moiseyenko VM, Tjulandin S et al. V-325 Study Group. Quality of life with docetaxel plus cisplatin and fluorouracil compared with cisplatin and fluorouracil from a phase III trial for advanced gastric or gastroesophageal adenocarcinoma: The V-325 Study Group. J Clin Oncol 2007; 25(22): 3210-3216.
9. Hsiang YH, Hertzberg R, Hecht S, Liu L. Camptothecin induces protein-linked DNA breaks via mammalian DNA topoisomerase I. J Biol Chem 1985; 260: 14873-14878.
10. Wu J, Yin MB, Hapke G et al. Induction of biphasic DNA double strand breaks and activation of multiple repair protein complexes by DNA topoisomerase I drug 7-ethyl-10-hydroxy-camptothecin. Mol Pharmacol 2002; 61: 742-748.
11. 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.
12. Dank M, Zaluski J, Barone C et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol 2008; 19: 1450-1457.
13. Bissery MC, Vrignaud P, Lavelle F. In vivo evaluation of the docetaxel-irinotecan combination. Proc Am Assoc Ca Res 1996; 37: 378 (Abstr 2578).
14. Pei XH, Nakanishi Y, Takayama K et al. Effect of CPT-11 in combination with other anticancer agents in lung cancer cells. Anticancer Drugs 1997; 8: 231-237.
15. Kano Y, Akutsu M, Tsunoda S et al. In vitro schedule-dependent interaction between paclitaxel and SN-38 (the active metabolite of irinotecan) in human carcinoma cell lines. Cancer Chemother Pharmacol 1998; 42: 91-98.
16. Bleickardt E, Argiris A, Rich R et al. Phase I dose escalation trial of weekly docetaxel plus irinotecan in patients with advanced cancer. Cancer Biol Ther 2002; 1: 646-650.
17. Adjei AA, Klein Cheri E, Kastrissios H et al. Phase I and pharmacokinetic study of irinotecan and docetaxel in patients with advanced solid tumors: Preliminary evidence of clinical activity. J Clin Oncol 2000; 18: 1116-1123.
18. Couteau C, Risse M-L, Ducreux M et al. Phase I and pharmacokinetic study of docetaxel and irinotecan in patients with advanced solid tumors. J Clin Oncol 2000; 18: 3545-3552.
19. Abigerges D, Armand JP, Chabot GG et al. Irinotecan (CPT-11) high-dose escalation using intensive high-dose loperamide to control diarrhea. J Natl Cancer Inst 1994; 86: 446-449.
20. World Health Organization. WHO Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland: World Health Organization Offset Publication No. 48, 1979.
21. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10: 1-10.
22. Koyama T, Chen H. Proper Inference from Simon's Two-Stage Designs. Stat Med 2008; 27(16): 3145-3154.
23. Govindan R, Read W, Faust J et al. Phase II study of docetaxel and irinotecan in metastatic or recurrent esophageal cancer: A preliminary report. Oncology (Williston Park) 2003; 17 (9 Suppl 8): 27-31.
24. Lordick F, von Schilling C, Bernhard H et al. Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer. Br J Cancer 2003; 89(4): 630-633.
25. Hoskins JM, Goldberg RM, Qu P et al. UGT1A1*28 genotype and irinotecan-induced neutropenia: Dose matters. J Natl Cancer Inst 2007; 99: 1290-1295.
26. Webb A, Cunningham D, Scarffe JH et al. Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol 1997; 15: 261-267.
27. Cunningham D, Starling N, Rao S et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 2008; 358: 36-46.
28. Gibson MK, Abraham SC, Wu TT et al. Epidermal growth factor receptor, p53 mutation, and pathological response predict survival in patients with locally advanced esophageal cancer treated with preoperative chemoradiotherapy. Clin Cancer Res 2003; 9: 6461-6468.
29. Pinto C, Di Fabio F, Siena S et al. Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study). Ann Oncol 2007; 18: 510-517.
30. Shah MA, Ramanathan RK, Ilson DH et al. Multicenter phase II study of irinotecan, cisplatin, and bevacizumab in patients with metastatic gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol 2006; 24: 5201-5206.
31. Wei J, Zou Z, Qian X et al. ERCC1 mRNA levels and survival of advanced gastric cancer patients treated with a modified FOLFOX regimen. Br J Cancer 2008; 98(8): 1398-1402.
32. Matsubara J, Nishina T, Yamada Y et al. Impacts of excision repair cross-complementing gene 1 (ERCC1), dihydropyrimidine dehydrogenase, and epidermal growth factor receptor on the outcomes of patients with advanced gastric cancer. Br J Cancer 2008; 98: 832-839.
33. Olaussen KA, Dunant A, Fouret P et al. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med 2006; 355: 983-991.