Phase 3 randomised study of canfosfamide (Telcyta®, TLK286) versus pegylated liposomal doxorubicin or topotecan as third-line therapy in patients with platinum-refractory or -resistant ovarian cancer

European Journal of Cancer

Volumn 45, Issue 13, 2009, Pages 2324-2332

  Vergote, I ^a   Finkler, N ^b   del Campo, J ^c   Lohr, A ^d   Hunter, J ^e   Matei, D ^f   Kavanagh, J ^g   Vermorken, J B ^h   Meng, L ⁱ   Jones, M ⁱ   Brown, G ⁱ   Kaye, S ^j  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b FLORIDA HOSPITAL CANCER INSTITUTE   (United States)

^c HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^d DR HORST SCHMIDT KLINIKEN   (Germany)

^e GREENVILLE HOSPITAL SYSTEM   (United States)

^f INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^h ANTWERP UNIVERSITY HOSPITAL   (Belgium)

ⁱ Telik Inc   (United States)

^j ROYAL MARSDEN HOSPITAL   (United Kingdom)

more..

Author keywords

Canfosfamide; Epithelial ovarian cancer; Glutathione S transferase; Platinum refractory or resistant; Prodrug

Indexed keywords

CANFOSFAMIDE; DOXORUBICIN; PLATINUM; TOPOTECAN;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BLOOD TOXICITY; BONE MARROW DEPRESSION; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONSTIPATION; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HUMAN; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVARY CANCER; PANCYTOPENIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STOMATITIS; THROMBOCYTOPENIA;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DOXORUBICIN; DRUG RESISTANCE, NEOPLASM; FEMALE; GLUTATHIONE; HUMANS; MIDDLE AGED; OVARIAN NEOPLASMS; POLYETHYLENE GLYCOLS; TOPOTECAN; TREATMENT OUTCOME;

EID: 68749089764     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2009.05.016     Document Type: Article

References (32)

1. Jemal A., Siegel R., Ward E., et al. Cancer statistics, 2006. CA Cancer J Clin 56 2 (2006) 106-130
2. Edwards B.K., Brown M.L., Wingo P.A., et al. Annual report to the nation on the status of cancer, 1975-2005, featuring population-based trends in cancer treatment. Journal of the National Cancer Institute 97 19 (2005) 1407-1427
3. Cannistra S.A., Bast Jr. R.C., Berek J.S., et al. Progress in the management of gynecologic cancer: consensus summary statement. J Clin Oncol 21 Suppl. 10 (2003) 129-132
4. Ozols R.F. Systemic therapy for ovarian cancer: current status and new treatments. Seminars in Oncology 33 Suppl. 6 (2006) 3-11
5. Greenlee R.T., Hill-Harmon M.B., Murray T., and Thun M. Cancer statistics, 2001. CA Cancer J Clin 51 1 (2001) 15-36
6. Markman M., and Bookman M.A. Second-line treatment of ovarian cancer. Oncologist 5 1 (2000) 26-35
7. Karabulut B., Sezgin C., Terek M.C., et al. Topotecan in platinum-resistant epithelial ovarian cancer. Chemotherapy 51 6 (2005) 347-351
8. Gordon A.N., Fleagle J.T., Guthrie D., Parkin D.E., Gore M.E., and Lacave A.J. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol 19 14 (2001) 3312-3322
9. Gordon A.N., Tonda M., Sun S., and Rackoff W. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol 95 1 (2004) 1-8
10. Mutch D.G., Orlando M., Goss T., et al. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol 25 19 (2007) 2811-2818
11. Cadron I., Leunen K., Amant F., Van Gorp T., Neven P., and Vergote I. The Leuven dose-dense paclitaxel/carboplatin regimen in patients with recurrent ovarian cancer. Gynecol Oncol 106 2007 (2007) 354-361
12. ™, a glutathione S-transferase P1-1 activated glutathione analog prodrug) in patients with platinum and paclitaxel refractory or resistant ovarian cancer. Int J Gynecol Cancer 15 4 (2005) 593-600
13. Satyam A., Hocker M.D., Kane-Maguire K.A., Morgan A.S., Villar H.O., and Lyttle M.H. Design, synthesis, and evaluation of latent alkylating agents activated by glutathione S-transferase. J Med Chem 39 8 (1996) 1736-1747
14. Lyttle M.H., Satyam A., Hocker M.D., et al. Glutathione-S-transferase activates novel alkylating agents. J Med Chem 37 10 (1994) 1501-1507
15. Meng F, Kim S, Brown GL, et al. TLK286-induced activation of the stress response apoptotic signaling pathway. In: Proceedings of the annual meeting of the American association for cancer research, April 6-10, 2002, San Francisco, California. Abstract #4772; p. 963.
16. ™ (TLK286). In: Proceedings of the annual meeting of the American association for cancer research, March 27-31, 2004, Orlando, Florida. Abstract #559; p. 129.
17. Dupont J., Aghajanian C., Andrea G., et al. Topotecan and liposomal doxorubicin in recurrent ovarian cancer: is sequence important. Int J Gynecol Cancer 16 S1 (2006) 68-73
18. Therasse P., Arbuck S.G., Eisenhauer E.A., et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92 3 (2000) 205-216
19. Vergote I, Finkler N, del Campo J, et al. Single agent, canfosfamide (C, TLK286) vs pegylated liposomal doxorubicin (D) or topotecan (T) in 3rd-line treatment of platinum (P) refractory or resistant ovarian cancer (OC): phase 3 study results. In: Proceedings of the annual meeting of the American society of clinical oncology, June 1-5, 2007, Chicago, IL. Abstract #LBA5528; p. 966s.
20. Cancer Therapy Evaluation Program. Common toxicity criteria (CTC), version 2.0. DCTD, NCI, NIH, DHHS, 1998 March; p. 1-35. ; 1998 [accessed 08.09.06].
21. Du Bois A., Quinn M., Thigpen T., et al. Consensus statements on the management of ovarian cancer: final document of the third international gynecologic cancer intergroup ovarian cancer consensus conference (GCIG OCCC). Ann Oncol 16 Suppl 8 (2004) viii7-viii12
22. Mutch D, Orlando M, Teneriello T, et al. Randomized phase III trial of gemcitabine (GEM) versus pegylated liposomal doxorubicin (PLDOX) for patients (pts.) with platinum-resistant (pt-r) ovarian cancer (oc) undergoing second or third-line chemotherapy (ct). In: Proceedings of ECCO 13 - the European cancer conference, October 30-November 3, 2005, Paris, France. Abstract #910; p. 262.
23. Xu H, Namgoong S-Y, Roth E, et al. Synergistic cancer cell cytotoxicity of TLK286 (Telcyta) in combination with carboplatin, cisplatin, doxorubicin, docetaxel, paclitaxel or oxaliplatin in human ovarian, lung, breast and colorectal cancer cell lines. In: Proceedings of the American association for cancer research, July 11-14, 2003, Washington, DC. Abstract #C156.
24. Xu H, Grossman E, Namgoong S-Y, et al. Enhanced antitumor activity of TLK286 in combination with oxaliplatin, carboplatin, doxorubicin, paclitaxel and docetaxel in human colorectal, ovarian and breast cancer cell lines. In: Proceedings of the annual meeting of the American association for cancer research, April 5-9, 2003, Toronto, Ontario, Canada. Abstract #1722; p. 390-1.
25. ™ (TLK286) in combination with paclitaxel, doxorubicin, carboplatin, oxaliplatin, cisplatin, docetaxel, gemcitabine and iressa in human cancer cells. In: Proceedings of the annual meeting of the American association for cancer research, March 27-31, 2004, Orlando, Florida. Abstract #2008; p. 462.
26. Wang Z, Keck JG, Brown GL, et al. TLK286, a novel glutathione analog prodrug, induces resensitization to carboplatin in human ovarian cancer, OVCAR3, platinum resistant cells. In: Proceedings of the annual meeting of the American association for cancer research, April 16-20, 2005, Anaheim, California. Abstract #1500; p. 351-2.
27. Keck J, Meng F, Grossman E, et al. Enhanced antitumor activity of TLK286 in combination with carboplatin, doxorubicin and docetaxel in human ovarian and breast cancer cell lines. In: Proceedings of the EORTC-NCI-AACR symposium on molecular targets and cancer therapeutics, November 19-22, 2002, Frankfurt, Germany. Abstract #102; p. S35.
28. ®) in platinum resistant ovarian cancer - results from 3 phase 2 Studies. In: Proceedings of the biennial international gynecologic cancer society meeting, October 3-7, 2004, Edinburgh, Scotland. Abstract #095; p. 28-9.
29. Rose P, Edwards R, Finkler N, et al. Phase 3 study: canfosfamide (C, TLK286) plus carboplatin (P) vs liposomal doxorubicin (D) as 2nd line therapy of platinum (P) resistant ovarian cancer (OC). In: Proceedings of the annual meeting of the American society of clinical oncology, June 1-5, 2007, Chicago, IL. Abstract #LBA5529; p. 281s.
30. Papadimitrakopoulou V, Boasberg P, Figlin R, et al. Phase 1-2a dose ranging study of TLK286 (a novel glutathione analog) in combination with docetaxel in platinum-resistant non-small cell lung cancer (NSCLC). In: Proceedings of the annual meeting of the American society of clinical oncology, June 5-8, 2004, New Orleans, Louisiana. Abstract #7140; p. 648.
31. Papadimitrakopoulou V, Edelman M, Zinner R, et al. Phases 1-2 dose ranging trial of TLK286 (TELCYTA) and cisplatin (C) as first-line treatment in advanced non-small cell lung cancer (NSCLC). In: Proceedings of the world conference on lung cancer, July 3-6, 2005, Barcelona, Spain. Abstract #P-550; p. S262-3.
32. Sequist L, Fidias P, Temel J, et al. Phase 2 multicenter dose-ranging trial of TLK286 (canfosfamide HCI) (T) in combination with carboplatin (C) and paclitaxel (P) as first-line treatment for advanced non-small cell lung cancer (NSCLC). In: Proceedings of the annual meeting of the American association for cancer research, April 14-18, 2007, Los Angeles, CA. Abstract #3521.