Comparison of gemcitabine versus the matrix metalloproteinase inhibitor BAY 12-9566 in patients with advanced or metastatic adenocarcinoma of the pancreas: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group

Journal of Clinical Oncology

Volumn 21, Issue 17, 2003, Pages 3296-3302

  Moore, Malcolm J ^a   Hamm, J ^a   Dancey, J ^a   Eisenberg, P D ^a   Dagenais, M ^a   Fields, A ^a   Hagan, K ^a   Greenberg, B ^a   Colwell, B ^a   Zee, B ^a   Tu, D ^a   Ottaway, J ^a   Humphrey, R ^a   Seymour, L ^a  

^a UNIVERSITY HEALTH NETWORK   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

GEMCITABINE; TANOMASTAT; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIMETABOLITE; DEOXYCYTIDINE; DRUG DERIVATIVE; ORGANIC COMPOUND;

ADVANCED CANCER; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; HUMAN; MAJOR CLINICAL STUDY; METASTASIS; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PANCREAS ADENOCARCINOMA; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; ADENOCARCINOMA; AGED; COMPARATIVE STUDY; DISEASE COURSE; FEMALE; MALE; MULTICENTER STUDY; NONPARAMETRIC TEST; PANCREAS TUMOR; PATHOLOGY; PHASE 3 CLINICAL TRIAL; PROPORTIONAL HAZARDS MODEL; SURVIVAL; TREATMENT OUTCOME;

ADENOCARCINOMA; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; DEOXYCYTIDINE; DISEASE PROGRESSION; FEMALE; HUMANS; MALE; NEOPLASM METASTASIS; ORGANIC CHEMICALS; PANCREATIC NEOPLASMS; PROPORTIONAL HAZARDS MODELS; QUALITY OF LIFE; STATISTICS, NONPARAMETRIC; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 0141688333     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.02.098     Document Type: Article

References (20)

1. Hertel LW, Boder GB, Kroin JS, et al: Evaluation of the antitumor activity of gemcitabine [2′, 2′-difluoro-2′-deoxycytidine]. Cancer Res 50:4417-4422, 1990
2. Burris H, Moore MJ, Andersen J, et al: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer A randomized trial. J Clin Oncol 15:2403-2413, 1997
3. Jones L, Ghaneh P, Humphreys M, et al: The matrix metalloproteinases and their inhibitors in the treatment of pancreatic cancer. Ann N Y Acad Sci 880:288-307, 1999
4. Sato H, Takino T, Okada Y, et al: A matrix metalloproteinase expressed on the surface of invasive tumour cells. Nature 370:61-65, 1994
5. Bramhall SR, Neoptolemos JP, Stamp GW, et al: Imbalance of expression of matrix metalloproteinases (MMPs) and tissue inhibitors of the matrix metalloproteinases (TIMPs) in human pancreatic carcinoma. J Pathol 182:347-355, 1997
6. Gatto C, Rieppi M, Borsotti P, et al: BAY12-9566, a novel inhibitor of matrix metalloproteinases with antiangiogenic activity. Clin Cancer Res 5:3603-3607, 1999
7. Erlichman C, Adjei AA, Alberts SR, et al: Phase I study of the matrix metalloproteinase inhibitor, BAY 12-9566. Ann Oncol 12:389-395, 2001
8. Heath EI, O'Reilly S, Humphrey R, et al: Phase I trial of the matrix metalloproteinase inhibitor BAY 12-9566 in patients with advanced solid tumours. Cancer Chemother Pharmacol 48:269-274, 2001
9. Hirte H, Goel R, Major P, et al: A phase I dose escalation study of the matrix metalloproteinase inhibitor BAY 12-9566 administered orally in patients with advanced solid tumours. Ann Oncol 11:1579-1584, 2000
10. Brundage M, Pater J, Zee B: Assessing the reliability of two toxicity scales: Implications for interpreting toxicity data. J Natl Cancer Inst 85:1138-1148, 1993
11. Aaronson NK, Ahmedzai S, Bergman B, et al: The European Organization for Research and Treatment of Cancer QLQ-C30: A quality of life instrument for use international clinical trials in oncology. J Natl Cancer Inst 85:365-379, 1993
12. Yellen SB, Cella DF, Webster, et al: Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage 13:63-74, 1997
13. Fleming TR: One sample multiple testing procedure for phase II clinical trials. Biometrics 38:143-151, 1982
14. Lan G, DeMets D: Discrete sequential boundaries for clinical trials. Biometrika 70:659-663, 1983
15. O'Brien PC, Fleming TR: A multiple testing procedure for clinical trials. Biometrics 35:549-556, 1979
16. Bramhall SR, Rosemurgy A, Brown PD, et al: Marimastat as first line therapy for patients with unresectable pancreatic cancer: A randomized trial. J Clin Oncol 19:3447-3455, 2001
17. Berlin J, Catalano P, Thomas JP, et al: Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma. J Clin Oncol 20:3270-3275, 2002
18. Colucci G, Giuliani F, Gebbia V, et al: Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and metastatic pancreatic carcinoma. Cancer 94:902-910, 2002
19. Bramhall SR, Schulz J, Nemunaitis J, et al: A double-blind placebo-controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer. Br J Cancer 87:161-167, 2002
20. Van Cutsem E, Karasek P, Oettle H, et al: Phase III trial comparing gemcitabine + R115777 (Zarnestra) versus gemcitabine plus placebo in advanced pancreatic cancer. Proc Am Soc Clin Oncol 21:517, 2002 (abstr 130a)