A multicenter, randomized trial of long-acting octreotide for the optimum prevention of chemotherapy-induced diarrhea: Results of the STOP trial

Journal of Supportive Oncology

Volumn 4, Issue 6, 2006, Pages 289-294

  Rosenoff, Stephen H ^a,b,c,d,e   Gabrail, Nashat Y ^a,b,c,d,e   Conklin, Richard ^a,b,c,d,e   Hohneker, John A ^a,b,c,d,e   Berg, William J ^a,b,c,d,e   Warsi, Ghulam ^a,b,c,d,e   Maloney, Jennifer ^a,b,c,d,e   Benedetto, John J ^a,b,c,d,e   Miles, Elizabeth A ^a,b,c,d,e   Zhu, Wei ^a,b,c,d,e   Anthony, Lowell ^a,b,c,d,e  

^a Oncology and Hematology Associates/US Oncology   (United States)

^b Gabrail Cancer Center   (United States)

^c Oncology Services of Aberdeen   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

^e Lousisiana State University School Health Services Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CAPECITABINE; CISPLATIN; DOCETAXEL; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; LONG ACTING DRUG; OCTREOTIDE; OXALIPLATIN; TOPOTECAN;

ADULT; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; CONSTIPATION; CONSULTATION; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FLATULENCE; FLUID THERAPY; GALLSTONE; HEALTH CARE PERSONNEL; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PARALLEL DESIGN; PATIENT SATISFACTION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; VOMITING; WEAKNESS;

ANTIDIARRHEALS; ANTINEOPLASTIC AGENTS; DELAYED-ACTION PREPARATIONS; DIARRHEA; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; OCTREOTIDE;

EID: 33746960799     PISSN: 15446794     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (22)

1. Benson AB 3rd, Ajani JA, Catalano RB, et al. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol 2004;22:2918-2926.
2. Leichman CG, Fleming TR, Muggia FM, et al. Phase II study of fluorouracil and its modulation in advanced colorectal cancer: a Southwest Oncology Group study. J Clin Oncol 1995;13:1303-1311.
3. Conti JA, Kemeny NE, Saltz LB, et al. Irinotecan is an active agent in untreated patients with metastatic colorectal cancer. J Clin Oncol 1996;14:709-715.
4. Rothenberg ML, Eckardt JR, Kuhn JG, et al. Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol 1996;14:1128-1135.
5. Blanke CD, Haller DG, Benson AB, et al. A phase II study of irinotecan with 5-fluorouracil and leucovorin in patients with previously untreated gastric adenocarcinoma. Ann Oncol 2001;12:1575-1580.
6. Arbuckle RB, Huber SL, Zacker C. The consequences of diarrhea occurring during chemotherapy for colorectal cancer: a retrospective study. Oncologist 2000;5:250-259.
7. Kornblau S, Benson AB, Catalano R, et al. Management of cancer treatment-related diarrhea: issues and therapeutic strategies. J Pain Symptom Manage 2000;19:118-129.
8. Petrelli N, Douglass HO Jr, Herrera L, et al. The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: a prospective randomized phase III trial. Gastrointestinal Tumor Study Group. J Clin Oncol 1989;7:1419-1426.
9. Rothenberg ML, Meropol NJ, Poplin EA, Van Cutsem E, Wadler S. Mortality associated with irinotecan plus bolus fluorouracil/leucovorin: summary findings of an independent panel. J Clin Oncol 2001;19:3801-3807.
10. Wadler S, Benson AB 3rd, Engelking C, et al. Recommended guidelines for the treatment of chemotherapy-induced diarrhea. J Clin Oncol 1998;16:3169-3178.
11. Cascinu S, Bichisao E, Amadori D, et al. High-dose loperamide in the treatment of 5-fluorouracil-induced diarrhea in colorectal cancer patients. Support Care Cancer 2000;8:65-67.
12. Cascinu S, Fedeli A, Fedeli SL, et al. Octreotide versus loperamide in the treatment of fluorouracil-induced diarrhea: a randomized trial. J Clin Oncol 1993;11:148-151.
13. Gebbia V, Carreca I, Testa A, et al. Subcutaneous octreotide versus oral loperamide in the treatment of diarrhea following chemotherapy. Anticancer Drugs 1993;4:443-445.
14. Zidan J, Haim N, Beny A, et al. Octreotide in the treatment of severe chemotherapy-induced diarrhea. Ann Oncol 2001;12:227-229.
15. Barbounis V, Koumakis G, Vassilomanolakis M, et al. Control of irinotecan-induced diarrhea by octreotide after loperamide failure. Support Care Cancer 2001;9:258-260.
16. Wadler S, Haynes H, Wiernik PH. Phase I trial of the somatostatin analog octreotide acetate in the treatment of fluoropyrimidine-induced diarrhea. J Clin Oncol 1995;13:222-226.
17. Rosenoff S. CID symptom resolution with long-acting octreotide. Presented at the 38th Annual Meeting of the American Society of Clinical Oncology. May 18-21, 2002. Orlando, Fla. Abstract 1545.
18. Rosenoff S. Octreotide LAR resolves severe chemotherapy-induced diarrhea (CID) and allows continuation of full-dose therapy. Presented at the 39th Annual Meeting of the American Society of Clinical Oncology. May 31-June 3, 2003. Chicago, Ill. Abstract 3126.
19. Rosenoff S. Resolution of refractory chemotherapy-induced diarrhea (CID) with octreotide long-acting formulation in cancer patients: 11 case studies. Support Care Cancer 2004;12:561-570.
20. National Cancer Institute. Common Toxicity Criteria Manual v2.0. Available at: http://ctep.cancer.gov/forms/CTCManual_v4_10-4-99.pdf. Accessed February 2005.
21. Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes 2003;1:79.
22. Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2004;2:12.