Phase II and Pharmacologie Study of Docetaxel as Initial Chemotherapy for Metastatic Breast Cancer

Journal of Clinical Oncology

Volumn 14, Issue 1, 1996, Pages 58-65

  Hudis, Clifford A ^a   Seidman, Andrew D ^b   Crown, John P A ^b   Balmaceda, Casilda ^b   Freilich, Ronnie ^b   Gilewski, Theresa A ^b   Hakes, Thomas B ^b   Currie, Violante ^b   Lebwohl, David E ^b   Baselga, Jose ^b   Raptis, George ^b   Gollub, Marc ^b   Robles, Marie ^b   Bruno, Rene ^b   Norton, Larry ^b  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CIMETIDINE; DEXAMETHASONE; DIPHENHYDRAMINE; DOCETAXEL; PACLITAXEL;

ABDOMINAL PAIN; ADULT; AGED; ANGIONEUROTIC EDEMA; ARTICLE; BREAST CARCINOMA; BRONCHOSPASM; CLINICAL ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG CLEARANCE; DRUG MECHANISM; DYSPNEA; FEMALE; FEVER; FLUID RETENTION; HUMAN; HYPERSENSITIVITY REACTION; HYPERTENSION; INTRAVENOUS DRUG ADMINISTRATION; LIVER DYSFUNCTION; METASTASIS; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BREAST NEOPLASMS; CIMETIDINE; DEXAMETHASONE; DIPHENHYDRAMINE; DRUG ADMINISTRATION SCHEDULE; DRUG HYPERSENSITIVITY; EDEMA; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; LEUKOPENIA; MIDDLE AGED; NEOPLASM METASTASIS; PACLITAXEL; PREMEDICATION; TAXOIDS;

EID: 0030051216     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.1.58     Document Type: Article

References (22)

1. Henderson IC: Principles in the management of metastatic disease, in Harris AL Jr. Henderson IC, Hellman S. et al (eds): Breast Diseases. Philadelphia, PA, Lippincott, 1991, pp 547-665
2. Holmes FA, Walters RS, Theriault HL, et al: Phase II trial of Taxol, an active drug in the treatment of metastatic breast cancer J Natl Cancer Inst 83:1797-1805, 1991
3. Reichman BS, Seidman AD, Crown JPA, et al: Paclitaxel and recombinant human granulocyte colony stimulating factor as initial chemotherapy for metastatic breast cancer. J Clin Oncol 11:1943-1951, 1993
4. Manfred JJ, Horwitz SB: Taxol: An antimitotic agent with a new mechanism of action. Pharmocol Ther 25:83-125, 1984
5. Seidman AD: The emerging role of paclitaxel in breast cancer therapy. Clin Cancer Res 1:247-256, 1995
6. Bissery MC, Guenard D, Gueritte-Voegelein F, et al: Experimental antitumor activity of Taxotere (RP 56976, NSC 628503), a Taxol analogue. Cancer Res 51:4845-4852, 1991
7. Gueritte-Voegelein F, Guenard D, Lavelle F: Relationships between the structure of Taxol analogues and their antimitotic activity. J Med Chem 34:992-998, 1991
8. Fromes Y, Gounon P, Bissery MC: Differential effects of taxol and taxotere (RP56976, NSC 628503) on Tau and MAP2-containing microtubules Proc Am Assoc Cancer Res 33:511 1992 (abstr)
9. Burris H, Irvin R, Kuhn J, et al: Phase I clinical trial of Taxotere administered as either a 2-hour or 6-hour intravenous infusion. J Clin Oncol 11:950-958, 1993
10. Bissett D, Setanoians A, Cassidy J, et al: Phase I and pharmacokinetic study of Taxotere (RP 56976) administered as a 24-hour infusion. Cancer Res 53:523-527, 1993
11. Pazdur R, Newman RA, Newman BM, et al: Phase I trial of Taxotere: Five-day schedule. J Nat Cancer Inst 84:1781-1788, 1992
12. Tomiak E, Piccart MJ, Kerger J, et al: Phase I study of docetaxel administered as a 1-hour intravenous infusion on a weekly basis. J Clin Oncol 12:1458-1467, 1994
13. Extra JM, Rousseau F, Bruno R, et al: Phase I and pharmacokinetic study of Taxotere (RP 56976; NSC 628503) given as a short intravenous infusion. Cancer Res 53:1037-1042, 1993
14. Bruno R, Cosson V, Vergniol JC, et al: Taxotere population pharmacokinetics. Proc Am Assoc Cancer Res 34:234, 1993 (abstr 1396)
15. Vergniol JC, Bruno R, Montay G, et al: Determination of Taxotere in human plasma by a semi-automated high-performance liquid chromatographic method. J Chromatogr 582:273-278, 1992
16. Beal SL, Boeckman AJ, Sheiner LB: NONMEM Users's Guide Part I-IV. San Francisco, CA, University of California at San Francisco, 1988-1992
17. Chevallier B, Fumoleau P, Kerbrat P, et al: Docetaxol is a major cytotoxic drug for the treatment of advanced breast cancer: A phase II trial of the Clinical Screening Cooperative Group of the European Organization for Research and Treatment of Cancer. J Clin Oncol 13:314-322, 1995
18. Trudeau ME, Eisenhauer E, Lofters W, et al: Phase II study of Taxotere as first line chemotherapy for metastatic breast cancer (MBC): A National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) study. Proc Am Soc Clin Oncol 12:64, 1993 (abstr)
19. Zimmerman GC, Keeling JH. Burns HA, et al: Acute cutaneous reactions to docetaxel (RP56976), a new chemotherapeutic agent. Arch Dermatol 131:202-206, 1995
20. Francis P, Bruno R, Seidman A, et al: Pharmacodynamics (PD) of docetaxel (Taxotere) in patients (pts) with liver metastases (mets) Proc Am Soc Clin Oncol 13:A346, 1994 (abstr)
21. Tomiak E, Kerger J, Lips S, et al: Unexpected pleural changes observed in patients treated with Taxotere (RP 56976): A new drug toxicity? Ann Oncol 3:189, 1992 (suppl 5, abstr)
22. 2 dose of docetaxel with prednisone premedication for patients with advanced non-small cell lung cancer. Cancer 75:968-972, 1995