Randomized Phase II Study of Irinotecan Plus Mitomycin C vs. Oxaliplatin Plus Mitomycin C in Patients with Advanced Fluoropyrimidine/Leucovorin-Pretreated Colorectal Cancer

REFERENCES

• Von Hoff D.D. Promising New Agents for Treatment of Patients with Colorectal Cancer. Semin. Oncol. 1998; 5(Suppl. 11)47–52
   Google Scholar
• Schmoll H.J., Büchele T., Schöber C. The Role of Second-Line Chemotherapy in Colorectal Cancer. Onkologie 1997; 20: 288–294
   Web of Science ®Google Scholar
• Rougier P., VanCutsem E., Bajetta E., , et al. Randomized Trial of Irinotecan vs. Fluorouracil by Continuous Infusion after Fluorouracil Failure in Patients with Metastatic Colorectal Cancer. Lancet 1998; 352: 1407–1412
   PubMed Web of Science ®Google Scholar
• Cunningham D., Pyrhönen S., James R.D., , et al. Randomized Trial of Irinotecan Plus Supportive Care vs. Supportive Care Alone after Fluorouracil Failure for Patients With Metastatic Colorectal Cancer. Lancet 1998; 352: 1413–1418
   PubMed Web of Science ®Google Scholar
• Bleiberg H., De Gramont A. Oxaliplatin plus 5-fluorouracil: Clinical Experience in Patients with Advanced Colorectal Cancer. Semin. Oncol. 1998; 5(Suppl. 5)32–39
   Google Scholar
• Cvitkovic E., Wasserman E., Goldwasser F., , et al. Preliminary Report on an Oxaliplatin (LOHP)/CPT-11 phase I trial in gastrointestinal (GI) malignancies: an active combination. Proc. Am. Soc. Clin. Oncol. 1997; 16: 229a
   Google Scholar
• Scheithauer W., Kornek G.V., Raderer M., , et al. Combined Irinotecan and Oxaliplatin Plus Granulocyte Colony-stimulating Factor in Patients with Advanced Fluoropyrimidine/ Leucovorin-pretreated Colorectal Cancer. J. Clin. Oncol. 1999; 17: 902–906
   PubMed Web of Science ®Google Scholar
• Genne P., Duchamp O., Brienza S., , et al. Oxaliplatin (l-OHP) in Combination with 5FU, Mitomycin C or Cyclophosphamide in a Model of Peritoneal Carcinomatosis Induced by Colon Cancer Cells in BD IX rats. Proc. Am. Assoc. Cancer Res. 1997; 38: 319
   Google Scholar
• Gil-Degado M.A., Antoine E.C., Bassot V., , et al. Final Results of a Phase I-II of CPT 11 (CPT)+Mitomycin C (MMC) Combination in Patients with Advanced Cancer of the Gastrointestinal System. Proc. Am. Soc. Clin. Oncol. 1998; 17: 268a
   Google Scholar
• Shimizu Y., Umezawa K., Utsugi K., , et al. Combination of CPT-11 with Mitomycin-C (MMC) for Platinum-refractory Clear Cell (CCA) and Mucinous (MCA) Adenocarcinoma of the Ovary. Proc. Am. Soc. Clin. Oncol. 1999; 18: 361a
   Google Scholar
• Yamao T., Kazami A., Handa T., , et al. Phase I/II Study of Irinotecan Combined with Mitomycin-C in Patients with Advanced Gastric Cancer. Proc. Am. Soc. Clin. Oncol. 1999; 18: 306a
   Google Scholar
• Simon R., Wittes R.E., Ellenberg S.S. Randomized Phase II Clinical Trials. Cancer Treat. Rep. 1985; 69: 1375–1381
   PubMedGoogle Scholar
• Hoskins P., Eisenhauer E., Beare S., , et al. Randomized Phase II Study of Two Schedules of Topotecan in Previously Treated Patients with Ovarian Cancer: a National Cancer Institute of Canada Clinical Trials Group study. J. Clin. Oncol. 1998; 16: 2233–2237
   PubMed Web of Science ®Google Scholar
• Pocock S.J., Simon R. Sequential Treatment Assignment with Balancing Prognostic Factors in the Controlled Clinical Trial. Biometrics 1975; 31: 3–15
   Google Scholar
• Handbook for Reporting Results of Cancer Treatment. WHO Offset Publication, Geneva, Switzerland 1979, No. 48
   Google Scholar
• Kaplan E.L., Meier P. Non-Parametric Estimation from Incomplete Observations. J. Am. Stat. Assoc. 1958; 53: 457–481
   Web of Science ®Google Scholar
• Von Hoff D.D, Rothenberg M.L., Pitot H.C., , et al. Irinotecan (CPT-11) Therapy for Patients with Previously Treated Metastatic Colorectal Cancer (CRC): Overall Results of FDA-Reviewed Pivotal US Clinical Trials. Proc. Am. Soc. Clin. Oncol. 1997; 16: 228a
   Google Scholar
• Van Cutsem E., Rougier P., Droz J.P., , et al. Clinical Benefit of Irinotecan (CPT-11) in Metastatic Colorectal Cancer (CRC) Resistant to 5-FU. Proc. Am. Soc. Clin. Oncol. 1997; 16: 268a
   Google Scholar
• Hoeffken K., Ridwelsky C., Wein A., , et al. Phase II Study of Irinotecan as Second Line Chemotherapy (CT) in Metastatic Colorectal Cancer (CRC). Proc. Am. Soc. Clin. Oncol. 1999; 18: 244a
   Google Scholar
• Frontini L., Labianca R., Sobrero A., , et al. Irinotecan (CPT-11) is Effective as Second-line Chemotherapy in Advanced Colorectal Cancer (ACC): A Phase II Trial of GISCAD (Italian Group for the Study of Gastrointestinal Cancer). Proc. Am. Soc. Clin. Oncol. 1999; 18: 260a
   Google Scholar
• Machover D., Diaz-Rubio E., de Gramont A., , et al. Two Consecutive Phase II Studies of Oxaliplatin (L-OHP) for Treatment of Patients with Advanced Colorectal Cancer who were Resistant to Previous Treatment with Fluoropyrimidines. Ann. Oncol. 1996; 7: 95–98
   PubMed Web of Science ®Google Scholar
• Levi F., Perpoint B., Garufi C. Oxaliplatin Activity Against Metastatic Colorectal Cancer. A Phase II Study of Five-day Continuous Venous Infusion at Circadian Rhythm Modulated Rate. Eur. J. Cancer 1993; 9(29A)1280–1284
   Google Scholar
• Saltz L.B., Locker P.K., Pirotta N., , et al. Weekly irinotecan (CPT-11), Leucovorin (LV), and Fluorouracil (FU) is Superior to Daily x5 LV/FU in Patients (PTS) with Previously Untreated Metastatic Colorectal Cancer (CRC). Proc. Am. Soc. Clin. Oncol. 1999; 18: 233a
   Google Scholar
• Douillard J.Y., Cunningham D., Roth A.D., , et al. A Randomized Phase III Trial Comparing Irinotecan (IRI) +5FU/Folinic Acid (FA) to the Same Schedule of 5FU/FA in Patients with Metastatic Colorectal Cancer (MCRC) as Front Line Chemotherapy (CT). Proc. Am. Soc. Clin. Oncol. 1999; 18: 233a
   Google Scholar
• Maiello E., Giuliani F., Gebbia V. Bi-monthly Folinic Acid (FA) and 5-Fluorouracil (FU) Bolus and Continuous Infusion Alone or with Irinotecan (CPT-11) for Advanced Colorectal Cancer (ACC): Preliminary Results of a Phase II Randomized Trial of the Southern Italy Oncology Group. Proc. Am. Soc. Clin. Oncol. 1999; 18: 242a
   Google Scholar
• De Gramont A., Figer A., Seymour M., , et al. A Randomized Trial of Leucovorin (LV) and 5- Fluorouracil (5FU) with or Without Oxaliplatin in Advanced Colorectal Cancer. Proc. Am. Soc. Clin. Oncol. 1998; 17: 257a
   Google Scholar
• Figer A., Louvet C., Homerin M., , et al. Analysis of Prognostic Factors of Overall Survival (OS) in a Randomized Trial of Bimonthly Leucovorin and 5-Fluorouracil Regimen (LVFU2) with or Without Oxaliplatin (OXA) in Advanced Colorectal Cancer. Proc. Am. Soc. Clin. Oncol. 1999; 18: 239a
   Google Scholar