Phase I dose-finding study of weekly single-agent patupilone in patients with advanced solid tumors

Journal of Clinical Oncology

Volumn 23, Issue 36, 2005, Pages 9120-9129

  Rubin, Eric H ^a   Rothermel, John ^a   Tesfaye, Fisseha ^a   Chen, Tianling ^a   Hubert, Martine ^a   Ho, Yu Yun ^a   Hsu, Chyi Hung ^a   Oza, Amit M ^a  

^a RUTGERS CANCER INSTITUTE OF NEW JERSEY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EPOTHILONE B; OCTREOTIDE; TAXANE DERIVATIVE; ANTINEOPLASTIC AGENT; EPOTHILONE DERIVATIVE;

ABDOMINAL PAIN; ACUTE KIDNEY FAILURE; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BILIRUBIN BLOOD LEVEL; BODY SURFACE; BONE MARROW SUPPRESSION; BREAST CANCER; CLINICAL TRIAL; COLON CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DOSE CALCULATION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EXPOSURE; DRUG FATALITY; DRUG HALF LIFE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG URINE LEVEL; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEMATOCHEZIA; HUMAN; LEG DISEASE; LEG NUMBNESS; LEUKOPENIA; LIVER DYSFUNCTION; LIVER FUNCTION; MAJOR CLINICAL STUDY; MALE; MAXIMUM ALLOWABLE CONCENTRATION; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVARY CANCER; PARESTHESIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTHROMBIN TIME; SIDE EFFECT; SOLID TUMOR; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING; DRUG ADMINISTRATION; HALF LIFE TIME; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; MULTICENTER STUDY; NEOPLASM;

ADULT; AGED; ANTINEOPLASTIC AGENTS; DRUG ADMINISTRATION SCHEDULE; EPOTHILONES; FEMALE; HALF-LIFE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS;

EID: 33644831567     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.03.0981     Document Type: Article

References (20)

1. Hamel E: Antimitotic natural products and their interactions with tubulin. Med Res Rev 16:207-231, 1996
2. Bollag DM, McQueney PA, Zhu J, et al: Epothilones, a new class of microtubule-stabilizing agents with a taxol-like mechanism of action. Cancer Res 55:2325-2333, 1995
3. Kearns CM, Gianni L, Egorin MJ: Paclitaxel pharmacokinetics and pharmacodynamics. Semin Oncol 22:16-23, 1995
4. Horwitz SB, Cohen D, Rao S, et al: Taxol: Mechanisms of action and resistance. J Natl Cancer Inst Monogr 55-61, 1993
5. Jordan MA, Wendell K, Gardiner S, et al: Mitotic block induced in HeLa cells by low concentrations of paclitaxel (Taxol) results in abnormal mitotic exit and apoptotic cell death. Cancer Res 56:816-825, 1996
6. Rowinsky EK: The development and clinical utility of the taxane class of antimicrotubule chemotherapy agents. Annu Rev Med 48:353-374, 1997
7. Yusuf RZ, Duan Z, Lamendola DE, et al: Paclitaxel resistance: Molecular mechanisms and pharmacologic manipulation. Curr Cancer Drug Targets 3:1-19, 2003
8. Rowinsky EK, Gilbert MR, McGuire WP, et al: Sequences of taxol and cisplatin: A phase I and pharmacologic study. J Clin Oncol 9:1692-1703, 1991
9. Weiss RB, Donehower RC, Wiernik PH, et al: Hypersensitivity reactions from Taxol. J Clin Oncol 8:1263-1268, 1990
10. Garrison JA, McCune JS, Livingston RB, et al: Myalgias and arthralgias associated with paclitaxel. Oncology (Williston Park) 17:271-277, 2003
11. Fossella FV, DeVore R, Kerr RN, et al: Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens: The TAX 320 Non-Small-Cell Lung Cancer Study Group. J Clin Oncol 18:2354-2362, 2000
12. Altmann KH, Wartmann M, O'Reilly T: Epothilones and related structures: A new class of microtubule inhibitors with potent in vivo antitumor activity. Biochim Biochim Biophys Acta 1470:M79-M91, 2000
13. Kowalski RJ, Giannakakou P, Hamel E: Activities of the microtubule-stabilizing agents epothilones A and B with purified tubulin and in cells resistant to paclitaxel (Taxol). J Biol Chem 272:2534-2541, 1997
14. O'Reilly T, McSheehy PM, Wenger F, et al: Patupilone (epothilone B, EP0906) inhibits growth and metastasis of experimental prostate tumors in vivo. Prostate 65:231-240, 2005
15. Martello LA, Verdier-Pinard P, Shen HJ, et al: Elevated levels of microtubule destabilizing factors in a Taxol-resistant/dependent A549 cell line with an alpha-tubulin mutation. Cancer Res 63:1207-1213, 2003
16. Green S, Weiss GR: Southwest Oncology Group standard response criteria, endpoint definitions and toxicity criteria. Invest New Drugs 10:239-253, 1992
17. Wadler S, Benson AB 3rd, Engelking C, et al: Recommended guidelines for the treatment of chemotherapy-induced diarrhea. J Clin Oncol 16:3169-3178, 1998
18. Kornblau S, Benson AB, Catalano R, et al: Management of cancer treatment-related diarrhea: Issues and therapeutic strategies. J Pain Symptom Manage 19:118-129, 2000
19. Mani S, McDaid H, Hamilton A, et al: Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors. Clin Cancer Res 10:1289-1298, 2004
20. Blum W, Aichholz R, Ramstein P, et al: In vivo metabolism of epothilone B in tumor-bearing nude mice: Identification of three new epothilone B metabolites by capillary high-pressure liquid chromatography/mass spectrometry/tandem mass spectrometry. Rapid Commun Mass Spectrom 15:41-49, 2001