Phase II clinical trial of the epothilone B analog, ixabepilone, in patients with non-small-cell lung cancer whose tumors have failed first-line platinum-based chemotherapy

Journal of Clinical Oncology

Volumn 25, Issue 23, 2007, Pages 3448-3455

  Vansteenkiste, Johan ^a   Lara Jr , Primo N ^b   Le Chevalier, Thierry ^b   Breton, Jean Luc ^b   Bonomi, Philip ^b   Sandler, Alan B ^b   Socinski, Mark A ^b   Delbaldo, Catherine ^b   McHenry, Brent ^b   Lebwohl, David ^b   Peck, Ronald ^b   Edelman, Mark ^b  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CARBOPLATIN; CISPLATIN; DOCETAXEL; ERLOTINIB; IXABEPILONE; PACLITAXEL; PEMETREXED; PLATINUM; TAXANE DERIVATIVE;

ADULT; ADVANCED CANCER; AGED; ALLERGIC REACTION; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONFUSION; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DESQUAMATION; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG WITHDRAWAL; EDEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEADACHE; HUMAN; HYPOXIA; INFECTION; INJECTION SITE REACTION; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAIL; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PAIN; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY FAILURE; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; TASTE DISORDER; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT FAILURE; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE PROGRESSION; EPOTHILONES; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; PLATINUM COMPOUNDS; TREATMENT OUTCOME;

EID: 34548158974     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2006.09.7097     Document Type: Article

References (29)

1. National Comprehensive Cancer Network: Practice Guidelines in Oncology: Version 2 - Non-Small Cell Lung Cancer, 2006. http://www.nccn.org/professionals/ physician_gls/PDF/nscl.pdf
2. Barlesi F, Pujol J, Daures J: Should chemotherapy (Cx) for advanced non-small cell lung cancer (NSCLC) be platinum-based? A literature-based meta-analysis of randomized trials. J Clin Oncol 23:673s, 2005 (suppl; abstr 7213)
3. Dooms C, Vansteenkiste J: Leading article: Importance of symptom management and attention to quality of life or clinical benefit of therapy in patients with advanced non-small cell lung cancer. Am J Cancer 3:281-290, 2004
4. NSCLC Collaborative Group: Chemotherapy in non-small cell lung cancer: A meta-analysis using updated data on individual patients from 52 randomised clinical trials. BMJ 311:899-909, 1995
5. Pfister D, Johnson D, Azzoli C: American Society of Clinical Oncology treatment of unresectable non-small cell lung cancer guidelines: Updated 2003. J Clin Oncol 22:330-353, 2004
6. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123-132, 2005
7. Hanna N, Shepherd FA, Fossella FV, et al: Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22:1589-1597, 2004
8. Jordan MA, Miller H, Ray A, et al: The Pat-21 breast cancer model derived from a patient with primary Taxol resistance recapitulates the phenotype of its origin, has altered β-tubulin expression and is sensitive to ixabepilone. Proc Amer Assoc Cancer Res 47:128, 2006 (abstr LB-280)
9. Wartmann M, Altmann KH: The biology and medicinal chemistry of epothilones. Curr Med Chem Anti-Cane Agents 2:123-148, 2002
10. Baselga J, Gianni L, Llombart A, et al: Predicting response to ixabepilone: Genomics study in patients receiving single agent ixabepilone as neoadjuvant treatment for breast cancer (BC). Breast Cancer Res Treat 94:S31, 2005 (abstr 305)
11. Fojo AT, Menefee ME, Poruchynsky M, et al: A translational study of ixabepilone (BMS-247550) in renal cell cancer (RCC): assessment of its activity and demonstration of target engagement in tumor cells. J Clin Oncol 23:388s, 2005 (suppl; abstr 4541)
12. Low JA, Wedam SB, Lee JJ, et al: Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in metastatic and locally advanced breast cancer. J Clin Oncol 23:2726-2734, 2005
13. O'Connor O, Straus D, Moskowitz C, et al: Targeting the microtubule apparatus in indolent and mantle cell lymphoma with the novel epothilone analog BMS-247550 induces major and durable remissions in very drug resistant disease. J Clin Oncol 23:577s, 2005 (suppl; abstr 6569)
14. Roché HH, Cure H, Bunnell C, et al: A Phase II study of epothilone analog BMS-247550 in patients (pts) with metastatic breast cancer (MBC) previously treated with an anthracycline. Proc Am Soc Clin Oncol 22:18, 2003 (abstr 69)
15. Smith SM, Pro B, van Besien K, et al: A phase II study of epothilone B analog BMS-247550 (NSC 710428) in patients with relapsed aggressive non-Hodgkin's lymphomas. J Clin Oncol 23:591s, 2005 (suppl; abstr 6625)
16. Conte P, Thomas E, Martin M, et al: Phase II study of ixabepilone in patients (pts) with taxane-resistant metastatic breast cancer (MBC): Final report. J Clin Oncol 24:568s, 2006 (suppl; abstr 10505)
17. Whitehead RP, McCoy S, Rivkin SE, et al: A phase II trial of epothilone B analogue BMS-247550 (NSC #710428) ixabepilone, in patients with advanced pancreas cancer: A Southwest Oncology Group study. Invest New Drugs 24:515-520, 2006
18. Zhuang SH, Menefee M, Kotz H, et al: A phase II clinical trial of BMS-247550 (ixabepilone), a microtubule-stabilizing agent in renal cell cancer. J Clin Oncol 22:394s, 2005 (suppl; abstr 4550)
19. Hussain M, Tangen CM, Lara PN Jr., et al: Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: A Southwest Oncology Group trial S0111. J Clin Oncol 23:8724-8729, 2005
20. Galsky MD, Small EJ, Oh WK, et al: Multiinstitutional randomized phase II trial of the epothilone B analog ixabepilone (BMS-247550) with or without estramustine phosphate in patients with progressive castrate metastatic prostate cancer. J Clin Oncol 23:1439-1446, 2005
21. Delbaldo C, Lara PN, Vansteenkiste J, et al: Phase II study of the novel epothilone BMS-247550 in patients (pts) with recurrent or metastatic non-small cell lung cancer (NSCLC) who have failed first-line platinum-based chemotherapy. Proc Am Soc Clin Oncol 21:303a, 2002 (abstr 1211)
22. Spriggs D, Soignet S, Bienvenu B, et al: Phase I first-in-man study of the epothilone B analog BMS-247550 in patients with advanced cancer. Proc Am Soc Clin Oncol 20:108a, 2001 (abstr 428)
23. Anderson S, Dizon D, Sabbatini P, et al: Phase I trial of BMS-247550 and gemcitabine in patients with advanced solid tumor malignancies. J Clin Oncol 22:151s, 2004 (suppl; abstr 2098)
24. Abraham J, Agrawal M, Bakke S, et al: Phase I trial and pharmacokinetic study of BMS-247550, an epothilone B analog, administered intravenously on a daily schedule for five days. J Clin Oncol 21:1866-1873, 2003
25. WHO: Handbook of Reporting Results of Cancer Treatment. Geneva, Switzerland, World Health Organisation, 1979
26. Simon R: Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1-10, 1989
27. Kaplan E, Meier P: Nonparametric estimation from incomplete observations, J Am Stat Assoc 53:457-481, 1958
28. Shepherd FA, Dancey J, Ramlau R, et al: Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18:2095-2103, 2000
29. 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