A Randomized Phase II Feasibility Trial of BMS-275291 in Patients with Early Stage Breast Cancer

Clinical Cancer Research

Volumn 10, Issue 6, 2004, Pages 1971-1975

  Miller, Kathy D ^a,h   Saphner, Thomas J ^b   Waterhouse, David M ^c   Chen, T T ^d   Rush Taylor, Anita ^a   Sparano, Joseph A ^e   Wolff, Antonio C ^f   Cobleigh, Melody A ^g   Galbraith, Susan ^d   Sledge, George W ^a  

^a INDIANA UNIVERSITY   (United States)

^b Green Bay Oncology   (United States)

^c Oncology Hematology Care   (United States)

^d BRISTOL MYERS SQUIBB   (United States)

^e Albert Einstein University   (United States)

^f JOHNS HOPKINS UNIVERSITY   (United States)

^g RUSH UNIVERSITY MEDICAL CENTER   (United States)

^h NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; MATRIX METALLOPROTEINASE INHIBITOR; PACLITAXEL; PLACEBO; REBIMASTAT; TAMOXIFEN;

ADULT; AGED; ARTHRALGIA; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER INHIBITION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG SAFETY; EARLY CANCER; FEMALE; HUMAN; INHIBITOR CONCENTRATION 90; MAJOR CLINICAL STUDY; MUSCULOSKELETAL DISEASE; MYALGIA; PHASE 2 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TENDON DISEASE;

AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DOXORUBICIN; FEMALE; HUMANS; IMIDAZOLES; MATRIX METALLOPROTEINASES; MIDDLE AGED; NEOPLASM STAGING; ORGANIC CHEMICALS; TAMOXIFEN;

EID: 12144287866     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-03-0968     Document Type: Article

References (24)

1. American Cancer Society. Cancer facts and figures 2002, Vol. 4, 2002.
2. Parker S, Tong T, Bolden S, Wingo PA. Cancer statistics, 1997. CA Cancer J Clin 1997;47:5-27.
3. Hidalgo M, Eckhardt SG. Development of matrix metalloproteinase inhibitors in cancer therapy. J Natl Cancer Inst (Bethesda) 2001;93:178-93.
4. Matrisian LM. Metalloproteinases and their inhibitors in matrix remodeling. Trends Genet 1990;6:121-5.
5. Kurizaki T, Toi M, Tominaga T. Relationship between matrix metalloproteinase expression and tumor angiogenesis in human breast carcinoma. Oncol Rep 1998;5:673-7.
6. Bergers G, Brekken R, McMahon G, et al. Matrix metalloproteinase-9 triggers the angiogenic switch during carcinogenesis. Nat Cell Biol 2000;2:737-44.
7. Azzam HS, Arand G, Lippman ME, Thompson EW. Association of MMP-2 activation potential with metastatic progression in human breast cancer cell lines independent of MMP-2 production. J Natl Cancer Inst (Bethesda) 1993;85:1758-64.
8. r 92,000 progelatinase levels correlate with spontaneous metastasis of rat 13762NF mammary adenocarcinoma. Cancer Res 1993;53:5802-7.
9. Cockett M, Murphy G, Birch M, et al. Matrix metalloproteinases and metastatic cancer. Biochem Soc Symp 1998;63:295-313.
10. Eccles S, Box G, Court W, Bone E, Thomas W, Brown P. Control of lymphatic and hematogenous metastasis of a rat mammary carcinoma by the matrix metalloproteinase inhibitor batimastat (BB-94). Cancer Res 1996;56:2815-22.
11. Sledge GW Jr, Qulali M, Goulet R, Bone EA, Fife R. Effect of matrix metalloproteinase inhibitor batimastat on breast cancer regrowth and metastasis in athymic mice. J Natl Cancer Inst (Bethesda) 1995;87:1546-50.
12. Naglich JG, Jure-Kunkel M, Gupta E, et al. Inhibition of angiogenesis and metastasis in two murine models by the matrix metalloproteinase inhibitor, BMS-275291. Cancer Res 2001;61:8480-5.
13. Bramhall S, Rosemurgy A, Brown P, Bowry C, Buckels JA. Marimastat as first-line therapy for patients with unresectable pancreatic cancer: a randomized trial. J Clin Oncol 2001;19:3447-55.
14. Bramhall SR, Schulz J, Nemunaitis J, Brown PD, Baillet M, Buckels JA. 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 2002;87:161-7.
15. Bramhall SR, Hallissey MT, Whiting J, et al. Marimastat as maintenance therapy for patients with advanced gastric cancer: a randomised trial. Br J Cancer 2002;86:1864-70.
16. Erlichman C, Adjei AA, Alberts SR, et al. Phase I study of the matrix metalloproteinase inhibitor, BAY 12-9566. Ann Oncol 2001;12:389-95.
17. Rudek MA, Figg WD, Dyer V, et al. Phase I clinical trial of oral COL-3, a matrix metalloproteinase inhibitor, in patients with refractory metastatic cancer. J Clin Oncol 2001;19:584-92.
18. Sparano JA, Bernardo P, Gradishar W, Ingle JN, Zucker S, Davidson NE. Randomized Phase II trial of marimastati versus placebo in patients with metastatic breast cancer who have responding or stable disease after first-line chemotherapy: an Eastern Cooperative Oncology Group trial (E2196). Proc Am Soc Clin Oncol 2002;21:44a.
19. Miller KD, Gradishar W, Schuchter L, et al. A randomized Phase II pilot trial of adjuvant marimastat in patients with early-stage breast cancer. Ann Oncol 2002;13:1220-4.
20. Lombard M, Wallace T, Kubicek M, et al. Synthetic matrix metalloproteinase inhibitors and tissue inhibitor of metalloproteinase (TIMP)-2, but not TIMP-1, inhibit shedding of tumor necrosis factor α receptors in a human colon adenocarcinoma. (Colo 205) cell line. Cancer Res 1998;58:4001-7.
21. Lockhart AC, Braun RD, Yu D, et al. Reduction of wound angiogenesis in patients treated with BMS-275291, a broad spectrum matrix metalloproteinase inhibitor. Clin Cancer Res 2003;9:586-93.
22. Daniels R, Guptaq E, Kollia G, et al. Safety and Pharmacokinetics of BMS-275291, a novel matrix metalloproteinase inhibitor in healthy subjects. Proc Am Soc Clin Oncol 2001;20a:100a.
23. Hurwitz HI, Humphrey JS, Williams K, et al. A Phase I trial of BMS-275291: a novel, non-hydroxamate, sheddase-sparing matrix metalloproteinase inhibitor (MMPI) with no dose-limiting arthritis. Proc Am Soc Clin Oncol 2001;20:98a.
24. Bryant J, Smith R, Margolese R, et al. Increased gallbladder adverse events associated with octreotide pa LAR in patients with breast cancer. Proc Am Soc Clin Oncol 2001;20:50a.