Phase 1/2 study of intravenous paclitaxel and oral cyclophosphamide in pretreated metastatic urothelial bladder cancer patients

Cancer

Volumn 115, Issue 3, 2009, Pages 517-523

  Lorenzo, Giuseppe Di ^a   Montesarchio, Vincenzo ^b   Autorino, Riccardo ^c   Bellelli, Teresa ^d   Longo, Nicola ^a   Imbimbo, Ciro ^a   Morelli, Emilio ^b   Giannarini, Gianluca ^e   Mirone, Vincenzo ^a   De Placido, Sabino ^a  

^a UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^b AO Cotugno ^*  (Italy)

^c SECOND UNIVERSITY OF NAPLES   (Italy)

^d San Luca Hospital   (Italy)

^e UNIVERSITY OF PISA   (Italy)

Author keywords

Combination; Metastatic bladder cancer; Oral cyclophosphamide; Paclitaxel; Survival

Indexed keywords

CISPLATIN; CYCLOPHOSPHAMIDE; DOXORUBICIN; GEMCITABINE; METHOTREXATE; PACLITAXEL; VINBLASTINE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; BLADDER CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG RESPONSE; FEMALE; HUMAN; MALE; MAXIMUM TOLERATED DOSE; METASTASIS; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SURVIVAL TIME; THROMBOCYTOPENIA; VOMITING;

ADMINISTRATION, ORAL; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM METASTASIS; PACLITAXEL; SURVIVAL RATE; URINARY BLADDER NEOPLASMS;

EID: 60049088481     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.24055     Document Type: Article

References (26)

1. Von der Maase H, Sengelov L, Roberts JT, et al. Longterm survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23:4602-4608.
2. Als AB, Sengelov L, Von der Maase H. Long-term survival after gemcitabine and cisplatin in patients with locally advanced transitional cell carcinoma of the bladder: focus on supplementary treatment strategies. Eur Urol. 2007;52: 478-486.
3. Roth BJ, Dreicer R, Einhorn LH, et al. Significant activity of paclitaxel in advanced transitional-cell carcinoma of the urothelium: a phase II trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 1994;12:2264-2270.
4. Vaughn DJ, Broome CM, Hussain M, et al. Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer. J Clin Oncol. 2002;20:937-940.
5. Miller KD, Sweeney CJ, Siedge GW. Redefining the target: chemotherapeutics as antiangiogenics. J Clin Oncol. 2001;19:1195-1206.
6. Bocci G, Francia G, Man S, et al. Thrombospondin 1, a mediator of the antiangiogenic effects of low-dose metronomic chemotherapy. Proc Natl Acad Sci USA. 2003;100:12917-12922.
7. Browder T, Buttefield C, Kraling B, et al. Antiangiogenic scheduling of chemotherapy improves efficacy against experimental drug resistant cancer. Cancer Res. 2000;60:1878-1886.
8. Di Lorenzo G, Autorino R, De Laurentiis M, et al. Thalidomide in combination with oral daily cyclophosphamide in patients with pretreated hormone refractory prostate cancer: a phase I clinical trial. Cancer Biol Ther. 2007;6:313-317.
9. Garcia AA, Hirte H, Fleming G, et al. Phase II clinical trial of bevacizumab and low-dose metronomic oral cyclophosphamide in recurrent ovarian cancer: a trial of the California, Chicago, and Princess Margaret Hospital phase II consortia. J Clin Oncol. 2008;26:76-82.
10. Bottini A, Generali D, Brizzi MP, et al. Randomized phase II trial of letrozole and letrozole plus low-dose metronomic oral cyclophosphamide as primary systemic treatment in elderly breast cancer patients. J Clin Oncol. 2006;24:3623-3628.
11. Therasse P, Arbuck SG, Eisenhauer EA, et al. ew guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Institute of Canada. J Natl Cancer Inst. 2000;92:205-216.
12. National Cancer Institute. Common Toxicity Criteria for Adverse Events. Version 3.0. Bethesda, MD: National Cancer Institute; 2003.
13. Otto T, Bex A, Krege S, et al. Paclitaxel-based second-line therapy for patients with advanced chemotherapy-resistant bladder carcinoma. Cancer. 1997;80:465-470.
14. Roth BJ, Bajorin DF. Advanced bladder cancer: the need to identify new agents in the post-M-VAC (methotrexate, vinblastine, doxorubicin and cisplatin) world. J Urol. 1995;153:894-900.
15. Kattan J, Culine S, Theodore C, et al. Phase II of ifosfamide, fluorouracil and folinic acid (FIFO regimen) in relapsed and refractory urothelial cancer. Cancer Invest. 1995;13:276-279.
16. Di Lorenzo G, Autorino R, Giordano A, et al. FOLFOX-4 in pre-treated patients with advanced transitional cell carcinoma of the bladder. Jpn J Clin Oncol. 2004;34:747-750.
17. Krege S, Rembrink V, Borgermann C, et al. Docetaxel and ifosfamide as second line treatment for patients with advanced or metastatic urothelial cancer after failure of platinum chemotherapy: a phase 2 study. J Urol. 2001;165:67-71.
18. Logothetis CJ, Hossan E, Sella A, et al. Fluorouracil and recombinant human interferon alfa-2a in the treatment of metastatic chemotherapy-refractory urothelial tumors. J Natl Cancer Inst. 1991;83:285-288.
19. Lorusso V, Pollera CF, Antimi M, et al. A phase II study of gemcitabine in patients with transitional cell carcinoma of the urinary tract previously treated with platinum. Italian Co-operative Group on Bladder Cancer. Eur J Cancer. 1998;34:1208-1212.
20. Sweeney CJ, Roth BJ, Kabbinavar FF, et al. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol. 2006;24:3451-347.
21. Culine S, Theodore C, De Santis M, et al. A phase II study of vinflunine in bladder cancer patients progressing after first-line platinum-containing regimen. Br J Cancer. 2006;94:1395-1401.
22. Bellmunt M, von der Maase H, Theodore C, et al. Randomised phase III trial of vinflunine (V) plus best supportive care (B) vs B alone as 2nd line therapy after a platinum- containing regimen in advanced transitional cell carcinoma of the urothelium (TCCU). Annual Meeting ASCO 2008. J Clin Oncol. 2008;26(15 suppl) Abstract 5028.
23. Rosenberg JE, Carroll PR, Small EJ. Update on chemotherapy for advanced bladder cancer. J Urol. 2005;174:14-20.
24. Sweeney CJ, Williams SD, Finch DE, et al. A Phase II study of paclitaxel and ifosfamide for patients with advanced refractory carcinoma of the urothelium. Cancer. 1999;86:514-518.
25. Kouno T, Ando M, Yonemori K, et al. Weekly paclitaxel and carboplatin against advanced transitional cell cancer after failure of a platinum-based regimen. Eur J Urol. 2007;52:1115-1122.
26. Uhm JE, Lim HY, Kim WS, et al. Paclitaxel with cisplatin as salvage treatment for patients with previously treated advanced transitional cell carcinoma of the urothelial tract. Neoplasia. 2007;9:18-22.