Phase II study of capecitabine and oxaliplatin as first-line treatment in advanced colorectal cancer

Annals of Oncology

Volumn 14, Issue 9, 2003, Pages 1378-1382

  Zeuli, Massimo ^a   Nardoni, C ^a   Pino, M S ^a   Gamucci, T ^b   Gabriele, A ^b   Ferraresi, V ^a   Giannarelli, D ^a   Cognetti, F ^a  

^a REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^b Umberto I Hospital   (Italy)

Author keywords

Advanced colorectal cancer; Capecitabine; First line chemotherapy; Oxaliplatin

Indexed keywords

ANTINEOPLASTIC AGENT; CAPECITABINE; CORTICOSTEROID; FLUOROURACIL; FOLINIC ACID; GRANISETRON; ONDANSETRON; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; COLORECTAL CANCER; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; HAND FOOT SYNDROME; HUMAN; LARYNX SPASM; LIVER DYSFUNCTION; MALE; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; STANDARD; STOMATITIS; SURVIVAL RATE; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS;

EID: 0141725528     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdg360     Document Type: Article

References (14)

1. Schuller J, Cassidy J, Dumont E et al. Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 2000; 45: 291-297.
2. Hoff PM, Ansari R, Batist G et al. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol 2001; 19: 2282-2292.
3. Van Cutsem E, Twelves C, Cassidy J et al. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol 2001; 19: 4097-4106.
4. Giacchetti S, Perpoint B, Zigani R et al. Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 2000; 18: 136-147.
5. de Gramont A, Figer A, Seymour M et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000; 18: 2938-2947.
6. Diaz-Rubio E, Evans TR, Tabernero J et al. Capecitabine (Xeloda) in combination with oxaliplatin: a phase I, dose-escalation study in patients with advanced or metastatic solid tumors. Ann Oncol 2002; 13: 558-565.
7. Zeuli M, Di Costanzo F, Sdrobolini A et al. Capecitabine and oxaliplatin in advanced colo-rectal cancer: a dose-finding study. Ann Oncol 2001; 12: 1737-1741.
8. Therasse P, Arbuck SG, Eisenhauer EA et al. New 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 Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 205-216.
9. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10: 1-10.
10. Arbuck SG. Overview of clinical trials using 5-fluorouracil and leucovorin for the treatment of colorectal cancer. Cancer 1989; 63: 1036-1044.
11. Bertheault-Cvitkovic F, Jami A, Ithzaki M et al. Biweekly intensified ambulatory chronomodulated chemotherapy with oxaliplatin, fluorouracil, and leucovorin in patients with metastatic colorectal cancer. J Clin Oncol 1996; 14: 2950-2958.
12. Andre T, Bensmaine MA, Louvet C et al. Multicenter phase II study of bimonthly high-dose leucovorin, fluorouracil infusion, and oxaliplatin for metastatic colorectal cancer resistant to the same leucovorin and fluorouracil regimen. J Clin Oncol 1999; 17: 3560-3568.
13. Sastre J, Butts C, Cassidy J et al. Capecitabine-oxaliplatin combination (XELOX), effective 1st line therapy for patients (pts) with metastatic colorectal cancer (MCRC): survival update of an international phase II trial. Ann Oncol 2002; 13 (Suppl 5): 88 (Abstr 288P).
14. Borner MM, Dietrich D, Stupp R et al. Phase II study of capecitabine and oxaliplatin in first- and second-line treatment of advanced or metastatic colorectal cancer. J Clin Oncol 2002; 20: 1759-1766.