Phase I trial of capecitabine and weekly irinotecan in combination with radiotherapy for neoadjuvant therapy of rectal cancer

Journal of Clinical Oncology

Volumn 23, Issue 7, 2005, Pages 1350-1357

  Hofheinz, Ralf Dieter ^a   Von Gerstenberg Helldorf, Bolko ^a   Wenz, Frederik ^a   Gnad, Ulrike ^a   Kraus Tiefenbacher, Uta ^a   Müldner, Albrecht ^a   Hehlmann, Rüdiger ^a   Post, Stefan ^a   Hochhaus, Andreas ^a   Willeke, Frank ^a  

^a MEDICAL FACULTY MANNHEIM HEIDELBERG UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; IRINOTECAN; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIMETABOLITE; CAMPTOTHECIN; DEOXYCYTIDINE; DRUG DERIVATIVE; RADIOSENSITIZING AGENT;

ADJUVANT THERAPY; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; CANCER ADJUVANT THERAPY; CANCER REGRESSION; CANCER STAGING; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; LEUKOPENIA; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROCTITIS; RADIATION DOSE; RECTUM CANCER; SIDE EFFECT; SKIN TOXICITY; STOMATITIS; THROMBOCYTOPENIA; VOMITING; DRUG ADMINISTRATION; DRUG COMBINATION; DRUG TOLERANCE; FEASIBILITY STUDY; MIDDLE AGED; PATHOLOGY; RECTUM TUMOR; TREATMENT OUTCOME;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS, PHYTOGENIC; CAMPTOTHECIN; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; DRUG TOLERANCE; FEASIBILITY STUDIES; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOADJUVANT THERAPY; RADIATION-SENSITIZING AGENTS; RECTAL NEOPLASMS; TREATMENT OUTCOME;

EID: 20144375332     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.04.171     Document Type: Article

References (37)

1. Kapiteijn E, Marijnen C, Nagtegaal I, et al: Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 345:638-646, 2001
2. Gastrointestinal Tumor Study Group: Prolongation of the disease-free interval in surgically treated rectal carcinoma. N Engl J Med 312:1465-1472, 1985
3. Krook JE, Moertel CG, Gunderson LL, et al: Effective surgical adjuvant therapy for high-risk rectal carcinoma. N Engl J Med 324:709-715, 1991
4. Sauer R: Adjuvant versus neoadjuvant combined modality treatment for locally advanced rectal cancer: First results of the German rectal cancer study (CAO/ARO/AIO-94). Int J Radiat Oncol Biol Phys 57:5124-5125, 2003 (suppl 2)
5. Tepper JE, O'Connell M, Niedzwiecki D, et al: Adjuvant therapy in rectal cancer: Analysis of stage, sex, and local control-final report of intergroup 0114. J Clin Oncol 20:1744-1750, 2002
6. O'Connell MJ, Martenson JA, Weiand HS, et al: Improving adjuvant therapy by combining protracted infusion fluorouracil with radiation therapy after curative surgery. N Engl J Med 331:502-507, 1994
7. Queißer W, Hartung G, Kopp-Schneider A, et al: For the study group Colon and Rectum Carcinoma, Mannheim: Adjuvant radio-chemotherapy with 5-fluorouracil and folinic acid in stage II, and III rectal cancer-12 vs. 6 months of therapy. Onkologie 23:334-339, 2000
8. Schüller J, Cassidy J, Dumont E, et al: Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 45:291-297, 2000
9. Twelves C, on behalf of the Xeloda Colorectal Cancer Group: Capecitabine as first-line treatment in colorectal cancer: Pooled data from two large, phase III trials. Eur J Cancer 38:15-20, 2002 (suppl 2)
10. Cassidy J, Twelves C, van Cutsem E, et al: First-line oral capecitabine therapy in metastatic colorectal cancer: A favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol 13:566-575, 2002
11. Scheithauer W, McKendrick J, Begbie S, et al: Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: Safety results of a randomized, phase III trial. Ann Oncol 14:1735-1743, 2003
12. Sawada N, Ishikawa T, Sekiguchi F, et al: X-ray irradiation induces thymidine phosphorylase and enhances the efficacy of capecitabine (Xeloda) in human cancer xenografts. Clin Cancer Res 5:2948-2953, 1999
13. Dunst J, Reese T, Sutter T, et al: Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer. J Clin Oncol 20:3983-3991, 2002
14. Dunst J, Reese T, Debus J, et al: Phase-II-study of preoperative chemoradiation with rectal cancer. Proc Am Soc Clin Oncol 23:260, 2004 (abstr 3559)
15. Rödel C, Grabenbauer GG, Papadopoulos T, et al: Phase I/II trial of capecitabine, oxaliplatin, and radiation for rectal cancer. J Clin Oncol 21:3098-3104, 2003
16. Glynne-Jones R, Sebag-Montefiore D, McDonald A, et al: A phase I study of preoperative radiation and capecitabine in combination with oxaliplatin in locally advanced rectal cancer. Proc Am Soc Clin Oncol 22:292, 2003 (abstr 1174)
17. Mitchell EP: Irinotecan in preoperative combined-modality therapy for locally advanced rectal cancer. Oncology (Huntingt) 14:56-59, 2000 (suppl 14)
18. Rich TA, Kirichenko AV: Camptothecin schedule and timing of administration with irradiation. Oncology (Huntingt) 15:37-41, 2001 (suppl 5)
19. Douillard JY, Cunningham D, Roth AD, et al: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: A multicentre randomised trial. Lancet 355:1041-1047, 2000
20. Saltz LB, Cox JV, Blanke C, et al: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer: Irinotecan Study Group. N Engl J Med 343:905-914, 2000
21. Mehta VK, Cho C, Ford JM, et al: Phase II trial of preoperative 3D conformal radiotherapy, protracted venous infusion 5-fluorouracil, and weekly CPT-11, followed by surgery for ultrasound-staged T3 rectal cancer. Int J Radiat Oncol Biol Phys 55:132-137, 2003
22. Voelter V, Stupp R, Matter M, et al: Preoperative hyperfractionated accelerated radiotherapy (HART) and concomitant CPT-11 in locally advanced rectal carcinoma: A phase I study. Int J Radiat Oncol Biol Phys 56:1288-1294, 2003
23. Navarro M, Dotor E, Rivera F, et al: A phase II study of irinotecan (CPT-11) and 5-fluorouracil (5-FU) concomitantly with preoperative radiotherapy (RT) in patients (pts) with locally advanced resectable rectal cancer. Proc Am Soc Clin Oncol 22:308, 2003 (abstr 1235)
24. Mitchell EP, Anne PR, Fry R, et al: Chemoradiation with CPT-11, 5-FU in neoadjuvant treatment of locally advanced or recurrent adenocarcinoma of the rectum: A phase I/II study update. Proc Am Soc Clin Oncol 22:262, 2003 (abstr 1052)
25. Levine EL, Gollins S, Susnerwala S, et al: Phase I/II study of irinotecan (CPT-11), 5-fluorouracil and concurrent radiotherapy for the treatment of T3-T4 locally advanced inoperable rectal cancer. Proc Am Soc Clin Oncol 22:345, 2003 (abstr 1384)
26. Klautke G, Kirchner R, Hopt U, et al: Continuous infusion of 5-FU and weekly irinotecan with concurrent radiotherapy as neoadjuvant treatment for locally advanced or recurrent rectal cancer. Proc Am Soc Clin Oncol 20:140a, 2001 (abstr 555)
27. Bajetta E, Di Bartolomeo M, Mariani L, et al: Randomized multicenter phase II trial of two different schedules of irinotecan combined with capecitabine as first-line treatment in metastatic colorectal carcinoma. Cancer 100:279-287, 2004
28. Tewes M, Schleucher N, Achterrath W, et al: Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer: Results of an extended phase I study. Ann Oncol 14:1442-1448, 2003
29. Kim JS, Kim JS, Cho MJ, et al: Preoperative chemoradiation using oral capecitabine in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys 54:403-408, 2002
30. Vanhoefer U, Harstrick A, Achterrath W, et al: Irinotecan in the treatment of colorectal cancer: Clinical overview. J Clin Oncol 19:1501-1518, 2001
31. Rougier P, Van Cutsem E, Bajetta E, et al: Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 352:1407-1412, 1998
32. Kirichenko AV, Rich TA, Newman RA, et al: Potentiation of murine MCa-4 carcinoma radioresponse by 9-amino-20(S)-camptothecin. Cancer Res 57:1929-1933, 1997
33. Mitchell EP, Winter K, Mohiuddin M, et al: Preoperative combined modality chemoradiation for distal rectal cancer: A randomized phase II RTOG trial. Proc Am Soc Clin Oncol 23:254, 2004 (abstr 3535)
34. Duck LR, Sempoux C, Honhon B, et al: A phase II study of preoperative oxaliplatin, capecitabine, and external beam radiotherapy in patients with locally advanced rectal adenocarcinoma. Proc Am Soc Clin Oncol 23:258, 2004 (abstr 3552)
35. Portelance L, Chao KS, Grigsby PW, et al: Intensity-modulated radiation therapy (IMRT) reduces small bowel, rectum, and bladder doses in patients with cervical cancer receiving pelvic and paraaortic irradiation. Int J Radiat Oncol Biol Phys 51:261-266, 2001
36. Janjan NA, Crane C, Feig BW, et al: Improved overall survival among responders to preoperative chemoradiation for locally advanced rectal cancer. Am J Clin Oncol 24:107-112, 2001
37. Köhne CH, van Cutsem E, Wils JA, et al: Irinotecan improves the activity of the AIO regimen in metastatic colorectal cancer: Results of EORTC GI Group study 40986. Proc Am Soc Clin Oncol 22:254, 2003 (abstr 1018)