A phase II study of gemcitabine at fixed infusion rate of 10 mg/m 2/min with or without immunotherapy in advanced renal cancer

Anticancer Research

Volumn 27, Issue 6 C, 2007, Pages 4461-4464

  Zustovich, Fable ^a   Cartei, Giuseppe ^a   Pastorelli, Davide ^a   Nicoletto, Ornella ^a   Gottardo, Fedra ^b   De Zorzi, Luca ^b   Dal Bianco, Massimo ^b  

^a VENETO INSTITUTE OF ONCOLOGY IOV IRCCS   (Italy)

^b ULSS 16   (Italy)

Author keywords

Gemcitabine; Immunotherapy; Kidney cancer

Indexed keywords

GEMCITABINE; INTERLEUKIN 2;

ADULT; AGED; ANEMIA; ARTICLE; CANCER GROWTH; CANCER RADIOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED STUDY; EDEMA; FATIGUE; FEMALE; FEVER; GRANULOCYTOPENIA; HUMAN; IMMUNOTHERAPY; KIDNEY CARCINOMA; LOW DRUG DOSE; MALE; MUCOSA INFLAMMATION; NAUSEA; NEPHRECTOMY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; DEOXYCYTIDINE; FEMALE; HUMANS; IMMUNOTHERAPY; INFUSIONS, INTRAVENOUS; INTERLEUKIN-2; KIDNEY NEOPLASMS; MALE; MIDDLE AGED;

EID: 37549060984     PISSN: 02507005     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

1. Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C and Thun MJ: Cancer statistics, 2006. CA Cancer J Clin 56(2): 106-130, 2006.
2. Zisman A, Pantuck AJ, Wieder J, Chao DH, Dorey F, Said JW, deKernion JB, Figlin RA and Belldegrun AS: Risk group assessment and clinical outcome algorithm to predict the natural history of patients with surgically resected renal cell carcinoma. J Clin Oncol 20(23): 4559-4566, 2002.
3. Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A and Ferrara J: Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol 17(8): 2530-2540, 1999.
4. Mickisch GH, Garin A van Poppel H, de Prijck L and Sylvester R: Radical nephrectomy plus interferon-alfa-based immuno-therapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet 22: 358(9286): 966-970, 2001.
5. Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, Caton JR, Munshi N and Crawford ED: Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med 345(23): 1655-1659, 2001.
6. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM and Figlin RA: Sutinib versus interferon alfa in metastatic renal cell carcinoma. N Engl J Med 356(2): 115-124, 2007.
7. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R and Bukowski RM: TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356(2): 125-134, 2007.
8. Negrier S: Better survival with interleukin-2-based regimens? Possibly only in highly selected patients. J Clin Oncol 22(7): 1174-1176, 2004.
9. Yagoda A, Abi-Rached B and Petrylak D: Chemotherapy for advanced renal-cell carcinoma: 1983-1993. Semin Oncol 22(1): 42-60, 1995.
10. Casali M, Marcellini M, Casali A, Giuntini T, Galante E and Ferrone C: Gemcitabine in pre-treated advanced renal carcinoma: a feasibility study. J Exp Clin Cancer Res 20(2): 195-198, 2001.
11. Daikeler T, Maas K, Hartmann JT, Kanz L and Bokemeyer C: Weekly short infusions of gemcitabine are not associated with suppression of lymphatic activity in patients with solid tumors. Anticancer Drugs 8(6): 643-644, 1997.
12. Nowak AK, Robinson BW and Lake RA: Synergy between chemotherapy and immunotherapy in the treatment of established murine solid tumors. Cancer Res 63(15): 4490-4496, 2003.
13. Grunewald R, Abbruzzese JL, Tarassoff P and Plunkett W: Saturation of 2′, 2′-difluorodeoxycytidine 5′-triphosphate accumulation by mononuclear cells during a phase I trial of gemcitabine. Cancer Chemother Pharmacol 27(4): 258-262, 1991.
14. Cartei G, Binato S, Trestin AR, Ceravolo R, Salmaso F, Pastorelli D, Zustovich F, Paganelli F, Mattiazzi M and Vattemi E: Phase II trial of gemcitabine as prolonged infusion in metastatic non-small-cell-lung-cancer. Lung Cancer 41(Suppl.2 s229): 545 Abstract, 2003.
15. Nanus DM, Garino A, Milowsky MI, Larkin M and Dutcher JP: Active chemotherapy for sarcomatoid and rapidly progressing renal cell carcinoma. Cancer 101(7): 1545-1551, 2004.
16. Zustovich F, Cartel G, Trestin A, Palù G, Palumbo M, Barzon L, Franchin E, Mattiazzi M, Binato S and Zovato S: Analysis of topoisomerase expression in PBMCs from patients undergoing chemotherapy for solid tumors. J Clin Oncol 2004 ASCO Annual Meeting Proceedings 14s(22): 2124, 2004.
17. Mertens WC, Eisenhauer EA, Moore M, Venner P, Stewart D, Muldal A and Wong D: Gemcitabine in advanced renal cell Carcinoma. A phase II study of the National Cancer Institute of Canada Clinical Trials Group. Ann Oncol 4(4): 331-332, 1993.
18. De Mulder PH, Weissbach L, Jakse G, Osieka R and Blatter J: Gemcitabine: a phase II study in patients with advanced renal cancer. Cancer Chemother Pharmacol 37(5): 491-495, 1996.
19. Rohde D, Thiemann D, Wildberger J, Wolff J and Jakse G: Treatment of renal cancer patients with gemcitabine (2′, 2′- difluorodeoxycytidine) and interferons: antitumor activity and toxicity. Oncol Rep 5(6): 1555-1560, 1998.
20. Rini BI, Vogelzang NJ, Dumas MC, Wade JL, Taber DA and Stadler WM: Phase II trial of weekly intravenous gemcitabine with continuous infusion fluorouracil in patients with metastatic renal cell cancer. J Clin Oncol 18(12): 2419-2426, 2000.
21. Ryan CW, Vogelzang NJ and Stadler WM: A phase II trial of intravenous gemcitabine and 5-fluorouracil with subcutaneous interleukin-2 and interferon-alpha in patients with metastatic renal cell carcinoma. Cancer 94(10): 2602-2609, 2002.
22. Porta C, Zimatore M, Imarisio I, Natalizi A, Sartore-Bianchi A, Danova M and Riccardi A: Gemcitabine and oxaliplatin in the treatment of patients with immunotherapy-resistant advanced renal cell carcinoma: final results of a single-institution Phase II study. Cancer 100(10): 2132-2138, 2004.
23. Waters JS, Moss C, Pyle L, James M, Hackett S, A'hern R, Gore M and Eisen T: Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma. Br J Cancer 91(10): 1763-1768, 2004.
24. Stadler WM, Halabi S, Rini B, Ernstoff MS, Davila E, Picus J, Barrier R and Small EJ: Cancer and Leukemia Group B: A phase II study of gemcitabine and capecitabine in metastatic renal cancer: a report of Cancer and Leukemia Group B: Cancer 107(6): 1273-1279, 2006.
25. George CM, Vogelzang NJ, Rini BI, Geoffroy FJ, Kollipara P and Stadler WM: A phase II trial of weekly intravenous gemcitabine and cisplatin with continuous infusion fluorouracil in patients with metastatic renal cell carcinoma. Ann Oncol 13(1): 116-120, 2002.
26. Massacesi C, Burattini L, Marcucci F and Bonsignori M: The efficacy of fixed dose rate infusion of gemcitabine combined with IFN-alpha2a in patients with advanced refractory renal cell carcinoma. J Interferon Cytokine Res 25(3): 165-168, 2005.
27. Ceribelli A, Gridelli C, De Marinis F, Fabi A, Gamucci T, Cortesi E, Barduagni M, Antimi M, Maione P, Migliorino MR, Giannarelli D and Cognetti F: Prolonged gemcitabine infusion in advanced non-small cell lung carcinoma: a randomized phase II study of two different schedules in combination with cisplatin. Cancer 98(2): 337-343, 2003.
28. Tempero M, Plunkett W, Ruiz Van Haperen V, Hainsworth J, Ho;chster H, Lenzi R and Abbruzzese J: Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. Clin Oncol 21(18): 3402-3408, 2003.