Phase II study of biweekly irinotecan and mitomycin C combination therapy in patients with fluoropyrimidine-resistant advanced colorectal cancer

Cancer Chemotherapy and Pharmacology

Volumn 52, Issue 2, 2003, Pages 125-130

  Yamada, Yasuhide ^a   Shirao, Kuniaki ^a   Hyodo, Ichinosuke ^b   Arai, Yasuaki ^c   Denda, Tadamichi ^d   Ambo, Tomonori ^e   Ohtsu, Atsushi ^f  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b NATIONAL HOSPITAL ORGANIZATION SHIKOKU CANCER CENTER   (Japan)

^c AICHI CANCER CENTER HOSPITAL   (Japan)

^d CHIBA CANCER CENTER   (Japan)

^e Sapporo Kosei General Hospital   (Japan)

^f NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

Author keywords

5 Fluorouracil; Colorectal cancer; Irinotecan; Mitomycin C; Phase II study; Refractory

Indexed keywords

DEXAMETHASONE; FLUOROPYRIMIDINE; IRINOTECAN; MITOMYCIN C; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SEROTONIN 3 ANTAGONIST;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD TOXICITY; BOLUS INJECTION; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER RECURRENCE; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG ACTIVITY; DRUG POTENTIATION; DRUG TOLERABILITY; FATIGUE; FEMALE; FEVER; HEMOLYTIC UREMIC SYNDROME; HUMAN; INFECTION; INTERSTITIAL PNEUMONIA; LEUKOPENIA; MALE; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG RESISTANCE, NEOPLASM; FEMALE; FLUOROURACIL; HUMANS; MALE; MIDDLE AGED; MITOMYCIN;

EID: 0042377457     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-003-0604-1     Document Type: Article

References (23)

1. Becouarn Y, Ychou M, Ducreaux M, Borel C, Bertheault-Cvitkovic F, Seitz JF, Nasca S, Nguyen TD, Paillot B, Raoul JL, Duffour J, Fandi A, Dupont-Andre G, Rougier P (1998) Phase II trial of oxaliplatin as first-line chemotherapy in metastatic colorectal cancer patients. J Clin Oncol 16:2739-2744
2. Comella P, Biglietto M, Casaretti R, De Lucia L, Avallone A, Maiorino L, Di Lullo L, De Cataldis G, Rivellini F, Comella G (2001) Irinotecan and mitomycin C in 5-fluorouracil-refractory colorectal cancer patients. Oncology 60:127-133
3. Conti JA, Kemeny NE, Saltz LB, Andre AM, Grossano DD, Bertino JR (1995) Continuous infusion fluorouracil/leucovorin and bolus mitomycin-C as a salvage regimen for patients with advanced colorectal cancer. Cancer 75:769-774
4. Cunningham D, Pyrhonen S, James RD, Punt CJA, Hickish TF, Heikkila R, Johannesen TB, Starkhammar H, Topham CA, Awad L, Jacques C, Herait P (1998) Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 352:1413-1418
5. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Grucia G, Awad L, Rougier P (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355:1041-1047
6. Fukuoka M, Niitani H, Suzuki A, Motomiya M, Hasegawa K, Nishiwaki Y, Kuriyama T, Ariyoshi Y, Negoro S, Masuda N (1992) A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancer. J Clin Oncol 10:16-20
7. Futatsuki K, Wakui A, Nakao I, Sakata Y, Kambe M, Shimada Y, Yoshino M, Taguchi T, Ogawa N (1994) Late phase II study of irinotecan hydrochloride (CPT-11) in advanced gastric cancer. CPT-11 Gastrointestinal Cancer Study Group. Jpn J Cancer Chemother 21:1033-1038
8. Goldberg RM, Morton RF, Sargent DJ, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP (2002) N9741: oxaliplatin (oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer. Initial toxicity and response data from a GI Intergroup Study. Proc ASCO 21:511
9. Kano Y, Suzuki K, Akutsu M, Suda K, Inoue Y, Yoshida M, Sakamoto S, Miura Y (1992) Effects of CPT-11 in combination with other anti-cancer agents in culture. Int J Cancer 50:604-610
10. Machover D, Diaz-Rubio E, De Gramont A, Schilf A, Gastiaburu JJ, Brienza S, Itzhaki M, Metzger G, N'Daw D, Vignoud J, Abad A, Francois E, Gamelin E, Marty M, Sastre J, Seitz JF, Ychou M (1996) Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines. Ann Oncol 7:95-98
11. Madarnas Y, Wbster P, Shorter AM, Bjarnason GA (2000) Irinotecan-associated pulmonary toxicity. Anticancer Drugs 11:709-713
12. Ross P, Norman A, Cunningham D, Webb A, Iveson T, Padhani A, Prendiville J, Watson M, Massey A, Popescu R, Oates J (1997) A prospective randomized trial of protracted venous infusion 5-fluorouracil with or without mitomycin C in advanced colorectal cancer. Ann Oncol 8:995-1001
13. Rougier P, Bugat R, Douillard JY, Culine S, Suc E, Brunet P, Becouarn Y, Ychou M, Marty M, Extra JM, Bonneterre J, Adenis A, Seitz JF, Ganem G, Namer M, Conroy T, Negrier S, Merrouche Y, Burki F, Mousseau M, Herait P, Mahjoubi M (1997) Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy. J Clin Oncol 15:251-260
14. Rougier P, Van Cutsem E, Bajetta E, Niederle N, Possinger K, Labianca R, Navarro M, Morant R, Bleiberg H, Wils J, Awad L, Herait P, Jacques C (1998) Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 352:1407-1412
15. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL (2000) Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 343:905-914
16. Scheithauer W, Kornek GV, Brugger S, Ullrich-Pur H, Valencak J, Raderer M, Fiebiger W, Kovats E, Lang F, Depisch D (2002) Randomized phase II study of irinotecan plus mitomycin C vs. oxaliplatin plus mitomycin C in patients with advanced fluoropyrimidine/leucovorin-pretreated colorectal cancer. Cancer Invest 20:60-68
17. The Advanced Colorectal Cancer Meta-Analysis Project (1992) Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. J Clin Oncol 10:896-903
18. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92:205-216
19. Verweij J, Van Zanten T, Souren T, Golding R, Pinedo HM (1987) Prospective study on the dose relationship of mitomycin C-induced interstitial pneumonitis. Cancer 60:756-761
20. Verweij J, Den Hartigh J, Pinedo HM (1990) Antitumor antibiotics. In: Chabner B, Collins JM (eds) Cancer chemotherapy - principles and practice. Lippincott, Philadelphia, p 382
21. Villalona-Calero MA, Kuhn J, Drengler R, Schaaf L, Otterson GA, Shapiro C, Thurman A, Diab S, Hammond L, Von Hoff D, Felton S, Hauger M, Monroe P, Rowinsky E, Kolesar J (2001) Pharmacologically-based phase I study of mitomycin-C as a modulator of irinotecan antitumor activity. Proc ASCO 20:400
22. World Health Organization (1970) Handbook for reporting results of cancer treatment (official publication no. 48). World Health Organization, Geneva
23. Yamao T, Shirao K, Matsumura Y, Muro K, Yamada Y, Goto M, Chin K, Shimada Y (2001) Phase I-II study of irinotecan combined with mitomycin-C in patients with advanced gastric cancer. Ann Oncol 12:1729-1735