Phase II study of ecteinascidin 743 in heavily pretreated patients with recurrent osteosarcoma

Cancer

Volumn 98, Issue 4, 2003, Pages 832-840

  Laverdiere, Caroline ^a   Kolb, E Anders ^a   Supko, Jeffrey G ^b   Gorlick, Richard ^a   Meyers, Paul A ^a   Maki, Robert G ^a   Wexler, Leonard ^a   Demetri, George D ^b   Healey, John H ^a   Huvos, Andrew G ^a   Goorin, Allen M ^b   Bagatell, Rochelle ^c   Ruiz Casado, Ana ^d   Guzman, Cecilia ^d   Jimeno, Jose ^d   Harmon, David ^b  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF ARIZONA   (United States)

^d PHARMAMAR S A   (Spain)

Author keywords

Ecteinascidin 743 (ET 743); Osteosarcoma; Phase II study; Sarcoma

Indexed keywords

BLEOMYCIN; CISPLATIN; DOXORUBICIN; IFOSFAMIDE; METHOTREXATE; OCTREOTIDE; TAMOXIFEN; TRABECTEDIN;

ADOLESCENT; ADULT; AGED; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DEHYDRATION; DOSE RESPONSE; DRUG ACTIVITY; DRUG INFUSION; DRUG RESPONSE; DRUG TOLERABILITY; FEMALE; FLUSHING; HUMAN; LIVER DYSFUNCTION; MALE; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; OPEN STUDY; OSTEOSARCOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RECURRENT CANCER; SALVAGE THERAPY; SCHOOL CHILD; SKIN MANIFESTATION; THROMBOCYTOPENIA; VOMITING;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC AGENTS, ALKYLATING; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE NEOPLASMS; CHILD; DIOXOLES; FEMALE; HUMANS; ISOQUINOLINES; MALE; MIDDLE AGED; OSTEOSARCOMA; SALVAGE THERAPY; TETRAHYDROISOQUINOLINES;

EID: 0043073206     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/cncr.11563     Document Type: Article

References (60)

1. Link MP, Gebhardt MC, Meyers PA. Osteosarcoma. In: Pizzo PA, Poplack DG, editors. Principles and practice of pediatric oncology, 4th edition. Philadelphia: Lippincott Williams & Wilkins, 2002:1051-1090.
2. Pastorino U, Gasparini M, Tavecchio L, et al. The contribution of salvage surgery to the management of childhood osteosarcoma. J Clin Oncol. 1991;9:1357-1362.
3. Tabone MD, Kalifa C, Rodary C, et al. Osteosarcoma recurrences in pediatric patients previously treated with intensive chemotherapy. J Clin Oncol. 1994;12:2614-2620.
4. Saeter G, Hoie J, Stenwig AE, et al. Systemic relapse of patients with osteogenic sarcoma: prognostic factors for long term survival. Cancer. 1995;75:1084-1093.
5. Gentet JC, Bruant-Mentigny M, Demaille MC, et al. Ifosfamide and etoposide in childhood osteosarcoma. A phase II study of the French Society of Paediatric Oncology. Eur J Cancer. 1997;33:232-237.
6. Ferrari S, Bacci G, Picci P, et al. Long-term follow-up and post-relapse survival in patients with non-metastatic osteosarcoma of the extremity treated with neoadjuvant chemotherapy. Ann Oncol. 1997;8:765-771.
7. Michelagnoli MP, Lewis IJ, Gattamaneni HR, et al. Ifosfamide/etoposide alternating with high-dose methotrexate: evaluation of a chemotherapy regimen for poor-risk osteosarcoma. Br J Cancer. 1999;79:1174-1178.
8. Fagioli F, Aglietta M, Tienghi A, et al. High-dose chemotherapy in the treatment of relapsed osteosarcoma: an Italian Sarcoma Group Study. J Clin Oncol. 2002;20:2150-2156.
9. Rodriguez-Galindo C, Daw NC, Kaste SC, et al. Treatment of refractory osteosarcoma with fractionated cyclophosphamide and etoposide. J Pediatr Hematol Oncol. 2002;24:250-255.
10. Goorin AM, Harris MB, Bernstein M, et al. Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: a Pediatric Oncology Group trial. J Clin Oncol. 2002;20:426-433.
11. Rinehart KL, Holt TG, Fregeau NL, et al. Ecteinascidins 729, 743, 745, 759A, 759B, and 770: potent antitumor agents from the Caribbean Tunicate Ecteinascidia turbinata. J Org Chem. 1990;55:4512-4515.
12. Jimeno J, Faircloth G, Cameron L, et al. Progress in the acquisition of new marine-derived anticancer compounds: development of ecteinascidin-743 (ET-743). Drugs Future. 1996;21:1155-1165.
13. Sakai R, Rinehart KL, Guan Y, et al. Additional antitumor ecteinascidins from a Caribbean tunicate: crystal structures and activities in vivo. Proc Natl Acad Sci U S A. 1992;89: 11456-11460.
14. Izbicka E, Lawrence R, Raymond E, et al. In vitro antitumor activity of the novel marine agent, Ecteinascidin-743 (ET-743, NSC-648766) against human tumors explanted from patients. Ann Oncol. 1998;9:981-987.
15. Hendricks HR, Fiebig HH, Giavazzi R, et al. High antitumour activity of ET743 against human tumour xenografts from melanoma, non-small-cell lung and ovarian cancer. Ann Oncol. 1999;10:1233-1240.
16. Li WW, Takahashi N, Jhanwar S, et al. Sensitivity of soft tissue sarcoma cell lines to chemotherapeutic agents: identification of ecteinascidin-743 as a potent cytotoxic agent. Clin Cancer Res. 2001;7:2908-2911.
17. Scotlandi K, Perdichizzi S, Manara MC, et al. Effectiveness of Ecteinascidin-743 against drug-sensitive and -resistant bone tumor cells. Clin Cancer Res. 2002;8:3893-3903.
18. Ghielmini M, Colli E, Erba E, et al. In vitro schedule-dependency of myelotoxicity and cytotoxicity of Ecteinascidin 743 (ET-743). Ann Oncol. 1998;9:989-993.
19. Takahashi N, Li WW, Banerjee D, et al. Sequence-dependent enhancement of cytotoxicity produced by ecteinascidin 743 (ET-743) with doxorubicin or paclitaxel in soft tissue sarcoma cells. Clin Cancer Res. 2001;7:3251-3257.
20. Pommier Y, Kohlhagen G, Bailly C, et al. DNA sequence- and structure-selective alkylation of guanine N2 in the DNA minor groove by Ecteinascidin 743, a potent antitumor compound from the Caribbean tunicate Ecteinascidia turbinata. Biochemistry. 1996;35:13303-13309.
21. Moore BM, Seaman FC, Wheelhouse RT, et al. Mechanism for the catalytic activation of Ecteinascidin 743 and its subsequent alkylation of guanine N2. J Am Chem Soc. 1998;120: 2490-2491.
22. Seaman FC, Hurley LH. Molecular basis for the DNA sequence selectivity of Ecteinascidin 736 and 743: evidence for the dominant role of direct readout via hydrogen bonding. J Am Chem Soc. 1998;120:13028-13041.
23. Takebayashi Y, Pourquier P, Yoshida A, et al. Poisoning of human DNA topoisomerase I by ecteinascidin 743, an anticancer drug that selectively alkylates DNA in the minor groove. Proc Natl Acad Sci U S A. 1999;96:7196-7201.
24. Zewail-Foote M, Hurley LH. Ecteinascidin 743: a minor groove alkylator that bends DNA toward the major groove. J Med Chem. 1999;42:2493-2497.
25. Bonfanti M, La Valle E, Fernandez Sousa Faro J-M, et al. Effect of ecteinascidin-743 on the interaction between DNA binding proteins and DNA. Anticancer Drug Des. 1999;14: 179-186.
26. Jin S, Gorfajn B, Faircloth G, et al. Ecteinascidin 743, a transcription-targeted chemotherapeutic that inhibits MDR1 activation. Proc Natl Acad Sci U S A. 2000;97:6775-6779.
27. Minuzzo M, Marchini S, Broggini M, et al. Interference of transcriptional activation by the antineoplastic drug ecteinascidin-743. Proc Natl Acad Sci U S A. 2000;97:6780-6784.
28. Garcia-Nieto R, Manzanares I, Cuevas C, et al. Increased DNA binding specificity for antitumor ecteinascidin 743 through protein-DNA interactions? J Med Chem. 2000;43: 4367-4369.
29. Friedman D, Hu Z, Kolb EA, et al. Ecteinascidin-743 inhibits activated but not constitutive transcription. Cancer Res. 2002;62:3377-3381.
30. Takebayashi Y, Goldwasser F, Urasaki Y, et al. Ecteinascidin 743 induces protein-linked DNA breaks in human colon carcinoma HCT116 cells and is cytotoxic independently of topoisomerase I expression. Clin Cancer Res. 2001;7:185-191.
31. Gajate C, An F, Mollinedo F. Differential cytostatic and apoptotic effects of Ecteinascidin-743 in cancer cells. J Biol Chem. 2002;44:41580-41589.
32. Garcia-Rocha M, Garcia-Gravalos MD, Avila J. Characterisation of antimitotic products from marine organisms that disorganise the microtubule network: ecteinascidin 743, isohomohalichondrin-B and LL-15. Br J Cancer. 1996;73:875-883.
33. Takebayashi Y, Pourquier P, Zimonjic DB, et al. Antiproliferative activity of ecteinascidin 743 is dependent upon transcription-coupled nucleotide-excision repair. Nat Med. 2001;7:961-966.
34. Zewail-Foote M, Li VS, Kohn H, et al. The inefficiency of incisions of ecteinascidin 743-DNA adducts by the UvrABC nuclease and the unique structural feature of the DNA adducts can be used to explain the repair-dependent toxicities of this antitumor agent. Chem Biol. 2001;8:1033-1049.
35. Erba E, Bergamaschi D, Bassano L, et al. Ecteinascidin-743 (ET-743), a natural marine compound, with a unique mechanism of action. Eur J Cancer. 2001;37:97-105.
36. D'Incalci M, Erba E, Damia G, et al. Unique features of the mode of action of ET-743. Oncologist. 2002;7:210-216.
37. D'Incalci M, Colombo T, Giavazzi G, et al. In human tumor xenografts the resistance to ET-743 or to cisplatin can be overcome by giving the two drugs in combination [abstract]. Eur J Cancer. 2002;38(Suppl 7):S34.
38. Taamma A, Misset JL, Riofrio M, et al. Phase I and pharmacokinetic study of ecteinascidin-743, a new marine compound, administered as a 24-hour continuous infusion in patients with solid tumors. J Clin Oncol. 2001;19:1256-1265.
39. Ryan DP, Supko JG, Eder JP, et al. Phase I and pharmacokinetic study of ecteinascidin 743 administered as a 72-hour continuous intravenous infusion in patients with solid malignancies. Clin Cancer Res. 2001;7:231-242.
40. Villalona-Calero MA, Eckhardt SG, Weiss G, et al. A phase I and pharmacokinetic study of ecteinascidin-743 on a daily × 5 schedule in patients with solid malignancies. Clin Cancer Res. 2002;8:75-85.
41. Twelves C, Misset JL, Villalona-Calero M, et al. Phase I trials with ET-743, a marine derived (MD) anticancer agent [abstract 1135]. Presented at European Cancer Conference, Vienna, Austria; September 12-16, 1999.
42. Demetri GD, Manola J, Harmon D, et al. Ecteinascidin-743 (ET-743) induces durable responses and promising 1-year survival rates in soft tissue sarcomas (STS): final results of phase II and pharmacokinetic studies in the U.S.A [abstract]. Proc Am Soc Clin Oncol. 2001;20:352a.
43. Delaloge S, Yovine A, Taamma A, et al. Preliminary evidence of activity of ecteinascidin (ET-743) in heavily pretreated patients with bone and soft tissue sarcomas (STS) [abstract]. Proc Am Soc Clin Oncol. 2000;19:554a.
44. Le Cesne A, Blay J-Y, Judson I, et al. ET-743 is an active drug in adult soft-tissue sarcoma: a STBSG-EORTC Phase II trial [abstract]. Proc Am Soc Clin Oncol. 2001;20:353a.
45. George S, Maki RG, Harmon D, et al. Phase II study of ecteinascidin-743 (ET-743) given by 3-hour IV infusion in patients with soft tissue sarcomas failing prior chemotherapies [abstract]. Proc Am Soc Clin Oncol 2002;21:408a.
46. Dileo P, Casali PG, Bacci G, et al. Phase II evaluation of 3-hr infusion ET-743 in patients with recurrent sarcomas [abstract]. Proc Am Soc Clin Oncol. 2002;21:408a.
47. Ruiz-Casado A, Lopez-Martin JA, Nieto A, et al. Ecteinascidin in heavily pretreated advanced sarcoma patients as a compassionate basis [abstract]. Proc Am Soc Clin Oncol. 2002;21:408a.
48. World Health Organization. Handbook for reporting results of cancer treatment. World Health Organization Offset Pub. No. 48. Geneva: World Health Organization, 1979.
49. Puchalski TA, Ryan DP, Garcia-Carbonero R, et al. Pharmacokinetics of ecteinascidin 743 administered as a 24-hour continuous intravenous infusion to adult patients with soft tissue sarcomas: associations with clinical characteristics, pathophysiological variables and toxicity. Cancer Chemother Pharmacol. 2002;50:309-319.
50. Casanova M, Casali PG, Sessa C, et al. Phase II study of 3-hour infusion of ET-743 in pretreated adult and pediatric patients with advanced/recurrent sarcomas - preliminary results from the Sendo and Italian Sarcoma Group [abstract O154]. Med Pediatr Oncol. 2002;39:257.
51. Baruchel S, Blaney S, Hershon L, et al. A phase 1 study of ET-743 in pediatric refractory solid tumors: a Children's Oncology Group study [abstract]. Proc Am Soc Clin Oncol. 2002;21:96a.
52. Harris MB, Cantor AB, Goorin AM, et al. Treatment of osteosarcoma with ifosfamide: comparison of response in pediatric patients with recurrent disease versus patients previously untreated: a Pediatric Oncology Group study. Med Pediatr Oncol. 1995;24:87-92.
53. Gomez J, Lopez Lazaro L, Guzman C, et al. Identification of biochemical parameters that predict the onset of severe toxicities in patients treated with ET-743 [abstract]. Proc Am Soc Clin Oncol. 2000;19:187a.
54. Lopez-Martin JA, Nieto A, Demetri GD, et al. Safety profile of ecteinascidin-743 (ET-743) in phase II clinical trials in adult patients with solid tumors [abstract]. Proc Am Soc Clin Oncol. 2002;21:96a.
55. Synold TW, Dussault I, Forman BM. The orphan nuclear receptor SXR coordinately regulates drug metabolism and efflux. Nat Med. 2001;7:584-590.
56. Riccardi R, Colombo T, Meco D, et al. Effective combinations of ET-743 and doxorubicin for tumor growth inhibitions against murine and human sarcomas in athymic mice [abstract]. Proc Am Assoc Cancer Res. 2001;42:211.
57. Kanzaki A, Takebayashi Y, Ren XQ, et al. Overcoming multidrug drug resistance in P-glycoprotein/MDR1-overexpressing cell lines by ecteinascidin 743. Mol Cancer Ther. 2002;1:1327-1334.
58. D'Incalci M, Erba E, Damia G, et al. The combination of ET-743 and cisplatin (DDP): from a molecular pharmacology study to a phase I clinical trial [abstract]. Proc Am Assoc Cancer Res. 2002;43:80.
59. Chabner BA. Cytotoxic agents in the era of molecular targets and genomics. Oncologist. 2002;7(Suppl 3):34-41.
60. Faircloth GT, Grant W, Jimeno J, et al. Dexamethasone potentiates the activity of Ecteinascidin 743 in preclinical melanoma and osteosarcoma models [abstract]. Proc Am Assoc Cancer Res. 2002;43:75.