Feasibility trial of methotrexate-paclitaxel as a second line therapy in advanced urothelial cancer

Cancer Investigation

Volumn 20, Issue 5-6, 2002, Pages 673-685

  Bellmunt, J ^a   Cos, J ^b   Cleries R ^c   Perez M ^c   Ribas, A ^a   Eres, N ^a   Murio, J E ^a   Margarit, C ^a   Baselga, J ^a  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^b BANC DE SANG I TEIXITS   (Spain)

^c UNIVERSITAT POLITÈCNICA DE CATALUNYA   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

METHOTREXATE; PACLITAXEL; PLATINUM DERIVATIVE; ANTINEOPLASTIC AGENT;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; BLADDER CANCER; BOLUS INJECTION; CANCER CELL CULTURE; CANCER PALLIATIVE THERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; COMPARATIVE STUDY; CONTINUOUS INFUSION; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG MIXTURE; DRUG POTENTIATION; DRUG TOXICITY; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; HUMAN TISSUE; KIDNEY FUNCTION; LUNG EMBOLISM; MALE; MEDICAL DOCUMENTATION; METASTASIS; MUCOSA INFLAMMATION; MUSCLE WEAKNESS; MYALGIA; NEUTROPENIA; PRIORITY JOURNAL; SENSORY NEUROPATHY; THROMBOCYTOPENIA; TRANSITIONAL CELL CARCINOMA; URINARY TRACT CANCER; URINARY TRACT INFECTION; UROGENITAL TRACT TUMOR; VOMITING; ADENOCARCINOMA; BLADDER TUMOR; CHEMICALLY INDUCED DISORDER; DRUG ADMINISTRATION; KIDNEY TUMOR; MIDDLE AGED; PALLIATIVE THERAPY; PATHOLOGY; PERIPHERAL NEUROPATHY; SQUAMOUS CELL CARCINOMA; SURVIVAL; TREATMENT OUTCOME;

ADENOCARCINOMA; AGED; AGED, 80 AND OVER; ANEMIA; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; CARCINOMA, TRANSITIONAL CELL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; KIDNEY NEOPLASMS; MALE; METHOTREXATE; MIDDLE AGED; NEUTROPENIA; PACLITAXEL; PALLIATIVE CARE; PERIPHERAL NERVOUS SYSTEM DISEASES; SURVIVAL ANALYSIS; TREATMENT OUTCOME; URINARY BLADDER NEOPLASMS;

EID: 0036052170     PISSN: 07357907     EISSN: None     Source Type: Journal    
DOI: 10.1081/CNV-120003536     Document Type: Article

References (40)

1. Harker, W.G.; Meyers, F.J.; Freiha, F.S.; Palmer, J.M.; Shortliffe, L.D. ; Hannigan, J.F.; McWhirter, K.M.; Torti, F.M. Cisplatin, Methotrexate, and Vinblastine (CMV): An Effective Chemotherapy Regimen for Metastatic Transitional Cell Carcinoma of the Urinary Tract: A Northern California Oncology Group Study. J. Clin. Oncol. 1985, 3, 1463-1470.
2. Sternberg, C.N.; Yagoda, A.; Scher, H.I.; Watson, R.C.; Herr, H.W.; Morse, M.J.; Sogani, P.C.; Vaughan, E.D.; Bander, N.; Weiselberg, L.R. M-VAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin) for Advanced Transitional Cell Carcinoma of the Urothelium. J. Urol. 1988, 139, 461-469.
3. Sternberg, C.N.; Yagoda, A.; Scher, H.I.; Watson, R.C.; Geller, N.; Herr, H.W.; Morse, M.J.; Sogani, P.C.; Vaughan, K.D.; Bander, N. Methotrexate, Vinblastine, Doxorubicin, and Cisplatin for Advanced Transitional Cell Carcinoma of the Urothelium: Efficacy and Patterns of Response and Relapse. Cancer 1989, 64, 2448-2458.
4. Bellmunt, J.; Ribas, A.; Eres, N.; Albanell, J.; Almanz, C.; Bermejo, B. ; Sole, L.A.; Baselga, J. Carboplatin Versus Cisplatin-Based Chemotherapy in the Treatment of Surgically Incurable Advanced Bladder Carcinoma. Cancer 1997, 80, 1966-1972.
5. Loehrer, P.J.; Einhorn, L.H.; Elson, P.J.; Crawford, E.D.; Kubler, P.; Tannock, I.; Regharam, D.; Stuart-Harris, R.; Sarosdy, M.F.; Lowe, B.A. A Randomized Comparison of Cisplatin Alone or in Combination with Methotrexate, Vinblastine, and Doxorubicin in Patients with Metastatic Urothelial Carcinoma: A Cooperative Group Study. J. Clin. Oncol. 1992, 10, 1066-1073.
6. Logothetis, C.J.; Dexeus, F.H.; Finn, L.; Sella, A.; Amato, R.J.; Ayala, A.G.; Kilbourn, R.G. A Prospective Randomized Trial Comparing MVAC and CISCA Chemotherapy for Patients with Metastatic Urothelial Tumors. J. Clin. Oncol. 1990, 8, 1050-1055.
7. Seidman, A.D.; Scher, H.I.; Heinemann, M.H.; Bajorin, D.F.; Sternberg, C.N.; Dershaw, D.D.; Silverberg, M.; Bosl, G.I. Continuous Infusion Gallium Nitrate for Patients with Advanced Refractory Urothelial Tract Tumors. Cancer 1991, 68, 2561-2565.
8. Witte, R.S.; Elson, P.; Bono, B.; Knop, R.; Richardson, R.R.; Dreicer, R.; Loehrer, PJ. Eastern Cooperative Oncology Group Phase II Trial of Ifosfamide in the Treatment of Previously Treated Advanced Urothelial Carcinoma. J. Clin. Oncol. 1997, 15 (2), 589-593.
9. Witte, R.S.; Elson, P.; Khandaker, J.; Trump, D.L. Eastern Cooperative Oncology Group Phase II Trial of Trimetrexate in Treatment of Advanced Urothelial Carcinoma. Cancer 1994, 73 (3), 688-691.
10. Pollera, C.F.; Ceribelli, A.; Grecco, M.; Calabresi, F. Weekly Gemcitabine in Advanced Bladder Cancer. A Preliminary Report from a Phase I Study. Ann. Oncol. 1994, 5, 182-184.
11. Roth, B.; Dreicer, R.; Einhorn, L.H.; Neuberg, D.; Johnson, D.H.; Smith, J.L.; Hudes, G.R.; Schultz, S.M.; Loehrer, P.J. Significant Activity of Paclitaxel in Advanced Transitional-Cell Carcinoma of the Urothelium: A Phase II Trial of the ECOG. J. Clin. Oncol. 1994, 12, 2264-2270.
12. Edelman, M.J.; Meyers, F.; Houston, J.; Lauder, I. Phase I Trial of Paclitaxel, Carboplatin and Methotrexate (MTX) with Granulocyte Colony-Stimulating Factor and Leucovorin in Advanced Transitional Cell Carcinoma. Semin. Oncol. 1997, 24 (5 Suppl. 1), S15-68-S15-71.
13. Bajorin, D.F.; McCaffrey, J.A.; Hilton, S.; Mazmudar, M.; Kelly, W.K.; Scher, H.I.; Spicer, J.; Herr, H.; Higgins, G. Treatment of Patients with Transitional-Cell Carcinoma of the Urothelial Tract with Ifosfamide, Paclitaxel and Cisplatin: A Phase II Trial. J. Clin. Oncol. 1998, 16, 2722-2727.
14. Redman, B.G.; Smith, D.C.; Flaherty, L.; Du, W.; Hussain, M. Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Advanced Urothelial Carcinoma. J. Clin. Oncol. 1998, 16, 1844-1848.
15. Burch, P.A.; Richardson, R.L.; Cha, S.S.; Sargent, D.J.; Pitot, H.C.; Kaur, J.S.; Camoriano, J.K. Phase II Study of Paclitaxel and Cisplatin for Advanced Urothelial Cancer. J. Urol. 2000, 164 (5), 1538-1542.
16. Von der Maase, H.; Andersen, L.; Crino, L.; Weinknecht, S.; Dogliotti, L. Weekly Gemcitabine and Cisplatin Combination Therapy in Patients with Transitional Cell Carcinoma of the Urothelium: A Phase II Clinical Trial. Ann. Oncol. 1999, 10, 1461-1465.
17. Stadler, W.M.; Kuzel, T.; Roth, B.; Raghavan, D.; Dorr, F.A. Phase II Study of Single-Agent Gemcitabine in Previously Untreated Patients with Metastatic Urothelial Cancer. J. Clin. Oncol. 1997, 15, 3441-3445.
18. Marini, L.; Sternberg, C.N.; Sella, A.; et al. A New Regimen of Gemcitabine and Paclitaxel in Previously Treated Patients with Advanced Transitional Cell Carcinoma. Proc. Am. Soc. Clin. Oncol. 1999, 18, 346, 1335.
19. Meluch, A.A.; Greco, F.A.; Burris, H.A.; Hainsworth, J.D. Gemcitabine and Paclitaxel Combination Therapy in Transitional Cell Carcinoma of the Urothelium. Eur. J. Cancer 2000, 36, S30-S33.
20. Huber, M.H.; Lee, J.S.; Newman, R.A.; Fosella, F.V.; Wester, M.; Hong, W.K.; Lippman, S.M. A Phase I Investigation of the Sequential Use of Methotrexate and Paclitaxel with and without G-CSF for the Treatment of Solid Tumors. Ann. Oncol. 1996, 7, 59-63.
21. Fuchs, D.A.; Johnson, R.K. Cytologic Evidence that Taxol, an Antineoplastic Agent from Taxus Brevifolia, Acts as a Mitotic Spindle Poison. Cancer Treat. Rep. 1978, 62, 1219-1222.
22. Niell, H.B.; Rangel, C.; Miller, A.; Cox, C. The Activity of Antimicrotubular Agents in Human Bladder Tumor Cell Lines (HBTCL). Proc. Am. Assoc. Cancer Res. 1993, 34, 202, 1025.
23. Rangel, C.; Niell, H.; Miller, A.; Cox, C. Taxol and Taxotere in Bladder Cancer: In Vitro Activity and Urine Stability. Cancer Chemother. Pharmacol. 1994, 33, 460-464.
24. Allegra, C.J.; Fine, R.L.; Drake, J.C.; Chabner, B.A. The Effect of Methotrexate on Intracellular Folate Pools in Human MCF-7 Breast Cancer Cells: Evidence for Direct Inhibition of Purine Synthesis. J. Biol. Chem. 1986, 26, 6478-6485.
25. Fernandes, D.J.; Sur, P.; Kute, T.E.; Capizzi, R.L. Proliferation-Dependent Cytotoxicity of Methotrexate in Murine L5718Y Leukemia. Cancer Res. 1988, 48, 5638-5644.
26. Cos, J.; Bellmunt, J.; Soler, C.; Ribas, A.; Liuis, J.M.; Murio, J.E.; Margarit, C. Comparative Study of Sequential Combinations of Paclitaxel and Methotrexate on a Human Bladder Cancer Cell Line. Cancer Investig. 2000, 18 (5), 429-435.
27. Chou, T.C. The Median Effect Principle and the Combination Index for Quantitation of Synergism and Antagonism. In Synergism and Antagonism in Chemotherapy; Chou, T.C., Rideout, D., Eds.; Academic Press: New York, 1991; 62-89.
28. Dreicer, R.; Gustin, D.; See, W.A.; Williams, R.D. Paclitaxel in Advanced Urothelial Carcinoma: Its Role in Patients with Renal Insufficiency and as Salvage Therapy. Proc. Am. Soc. Clin. Oncol. 1996, 15, 242-243, Abstract 607.
29. Gehan, E.A. The Determination of the Number of Patients Required in a Preliminary and Follow-Up Trial of a New Chemotherapeutic Agent. J. Chronic Dis. 1961, 13, 346-353.
30. Kaplan, E.L.; Meier, P. Nonparametric Estimation from Incomplete Observations. J. Am. Stat. Assoc. 1958, 53, 457-481.
31. Kaufmann, S.H.; Peereboom, D.; Buckwalter, C.A.; Svingen, P.A.; Grochow, L.B.; Donehower, R.C.; Rowinsky, E.K. Cytotoxic Effects of Topotecan Combined with Various Anticancer Agents in Human Cancer Cell Lines. J. Natl Cancer Inst. 1996, 88, 734-741.
32. SAS Institute Inc, User's Guide; SAS: Cary, NC, 1995.
33. Tu, S.M.; Hossan, E.; Amato, R.; Kilbourn, R.; Logothetis, C.J. Paclitaxel, Cisplatin and Methotrexate Combination Chemotherapy is Active in the Treatment of Refractory Urothelial Malignancies. J. Urol. 1995, 154, 1719-1722.
34. Otto, T.; Bex, A.; Krege, S.; Walz, P.H.; Rubben, H. Paclitaxel-Based Second-Line Therapy for Patients with Advanced Chemotherapy-Resistant Bladder Carcinoma (MI): A Clinical Phase II Study. Cancer 1997, 80, 465-470.
35. McCaffrey, J.A.; Hilton, S.; Mazumdar, M.; Sadan, S.; Kelly, W.K.; Scher, H.L.; Bajorin, D.F. Phase II Trial of Docetaxel in Patients with Advanced or Metastatic Transitional Cell Carcinoma. J. Clin. Oncol. 1997, 15, 1853-1857.
36. Chou, T.C.; Otter, G.M.; Sirotnak, F.M. Combined Effects of Edatrexate with Taxol or Taxotere Against Breast Cancer Cell Growth. Proc. Am. Assoc. Cancer Res. 1993, 34, 300, Abstract 789.
37. Berenbaum, M.C. What Is Synergy? Pharmacol. Rev. 1989, 41, 93-141.
38. Machado, S.G.; Robinson, G.A. A Direct, General Approach Based on Isobolograms for Assessing the Joint Action of Drugs in Pre-Clinical Experiments. Stat. Med. 1994, 13, 2289-2309.
39. Laska, E.M.; Meisner, M.; Tang, D.I. Classification of the Effectiveness of Combination Treatments. Stat. Med. 1997, 16, 2211-2228.
40. Chou, T.C.; Talalay, P. Quantitative Analysis of Dose-Effect Relationships: The Combined Effects of Multiple Drugs or Enzyme Inhibitors. Adv. Enzyme Regul. 1987, 22, 27-55.