Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer

Clinical Cancer Research

Volumn 10, Issue 24, 2004, Pages 8147-8151

  Dagher, Ramzi N ^a   Li, Ning ^a   Abraham, Sophia ^a   Rahman, Atiqur ^a   Sridhara, Raji ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANDROGEN; DEXAMETHASONE; DOCETAXEL; MITOXANTRONE; PREDNISONE;

ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CARDIOTOXICITY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COUGHING; DESQUAMATION; DIARRHEA; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG METABOLISM; DRUG SAFETY; DYSPNEA; EDEMA; EPIPHORA; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FLUID RETENTION; HEART LEFT VENTRICLE FAILURE; HUMAN; INFECTION; LACRIMATION; MOTOR NEUROPATHY; MYALGIA; NAIL DISEASE; NAUSEA; NEUTROPENIA; PERIPHERAL EDEMA; PHARYNGITIS; PRIORITY JOURNAL; PROSTATE CANCER; RASH; REVIEW; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; TASTE DISORDER; THROMBOCYTOPENIA; TREATMENT OUTCOME; WEIGHT GAIN;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DRUG APPROVAL; DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; MITOXANTRONE; NEOPLASMS, HORMONE-DEPENDENT; PREDNISONE; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; SURVIVAL RATE; TAXOIDS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 11144229621     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-04-1402     Document Type: Review

References (18)

1. Pienta KJ, Sandler H, Javidan J, Sanda MG. Prostate cancer. In: Pazdur R, Coia LR, Hoskins WJ, Wagman LD, editors. Cancer management: a multidisciplinary approach. 7th ed. New York: The Oncology Group; 2003. p. 361-82.
2. Ryan CJ, Small EJ. Advances in prostate cancer. Curr Opin Oncol 2004;16:242-6.
3. Fifty-first meeting of the Oncology Drugs Advisory Committee of FDA; Gaithersburg, Maryland. September 11, 1996.
4. Tannock IF, Osoba D, Stockler MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996;14:1756-64.
5. Picus J, Schultz M. Docetaxel as monotherapy in the treatment of hormone-refractory prostate cancer: preliminary results. Semin Oncol 1999;26(5 Suppl):14-8.
6. Friedland D, Cohen J, Miller R Jr, et al. A Phase II trial of Docetaxel in hormone-refractory prostate cancer: correlation of anti-tumor effect to phosphorylation of Bcl-2. Semin Oncol 1999;26(5 Suppl):19-23.
7. Beer TM, Pierce WC, Lowe BA, et al. Phase II study of weekly Taxotere in symptomatic androgen-independent prostate cancer. Ann Oncol 2001;12:1273-79.
8. Petrioli R, Pozzessere D, Messinese S, et al. Weekly low-dose Taxotere in advanced hormone-refractory prostate cancer subjects previously exposed to chemotherapy. Oncology (Basel) 2003;64:300-5.
9. Berry W, Dakhil S, Gregurich MA, et al. Phase II trial of single-agent weekly Taxotere in hormone-refractory, symptomatic, metastatic carcinoma of the prostate. Semin Oncol 2001;28(15 Suppl):8-15.
10. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988;75:800-2.
11. Pichard L, Fabre I, Daujat M, et al. Effect of corticosteroids on the expression of cytochromes P450 and on cyclosporin A oxidase activity in primary cultures of human hepatocytes. Molecular Pharm 1992;41:1047-55.
12. Marre F, Sanderink GJ, de Sousa G, et al. Hepatic biotransformation of docetaxel (Taxotere) in vitro: involvement of the CYP3A subfamily in humans. Cancer Res 1996;56:1296-302.
13. Wang LZ, Goh BC, Grigg ME, et al. A rapid and sensitive liquid chromatography/tandem mass spectrometry method for determination of docetaxel in human plasma. Rapid Commun Mass Spectrom 2003;17:1548-52.
14. Bruno R, Hille D, Riva A, et al. Population pharmacokinetics/ pharmacodynamics (PK/PD) of docetaxel in phase 2 studies in subjects with cancer. J Clin Oncol 1998;16:187-96.
15. Bruno R, Vivier N, Veyrat-Follet C, Montay G, Rhodes GR. Population pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for docetaxel. Investig New Drugs 2001;19:163-9.
16. Hussain M, Petrylak D, Fisher E, Tangen C, Crawford D. Docetaxel and estramustine versus mitoxantrone and prednisone for hormone-refractory prostate cancer: scientific basis and design of Southwest Oncology Group Study 9916. Semin Oncol 1999;26(5 Suppl 17):55-60.
17. Petrylak DP, Tangen C, Hussain M, et al. SWOG 99-16: randomized phase III trial of docetaxel/estramustine versus mitoxantrone/prednisone in men with androgen-independent prostate cancer [abstract 3, plenary session]. Am Soc Clin Oncol Proc 2004.
18. Petrylak DP. Examination of end points in the SWOG Docetaxel trial. Prostate Cancer Endpoints Workshop; Bethesda, Maryland. June 22, 2004.