Phase i trial of autologous hematopoietic SCT with escalating doses of topotecan combined with CY and carboplatin in patients with relapsed or persistent ovarian or primary peritoneal carcinoma

Bone Marrow Transplantation

Volumn 45, Issue 3, 2010, Pages 490-497

  Litzow, M R ^a   Peethambaram, P P ^a   Safgren, S L ^a   Keeney, G L ^a   Ansell, S M ^a   Dispenzieri, A ^a   Elliott, M A ^a   Gastineau, D A ^a   Gertz, M A ^a   Inwards, D J ^a   Lacy, M Q ^a   Micallef, I N M ^a   Porrata, L F ^a   Lingle, W L ^a   Hartmann, L C ^a   Frost, M H ^a   Barrette, B A ^a   Long, H J ^a   Suman, V J ^a   Reid, J M ^a   Ames, M M ^a   Kaufmann, S H ^a   more..

^a MAYO CLINIC CANCER CENTER   (United States)

Author keywords

Autologous hematopoietic stem cell transplantation; Phase I; Topotecan

Indexed keywords

CARBOPLATIN; CYCLOPHOSPHAMIDE; DNA TOPOISOMERASE; GRANULOCYTE COLONY STIMULATING FACTOR; KI 67 ANTIGEN; PLATINUM; PROTEIN BCL 2; TOPOTECAN;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION; BLEEDING; CANCER MORTALITY; CANCER RELAPSE; CATHETER INFECTION; CLINICAL TRIAL; CONTINUOUS INFUSION; DEHYDRATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; EPISTAXIS; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPOKALEMIA; HYPONATREMIA; IMMUNOHISTOCHEMISTRY; INFECTION; LEUKOPENIA; NAUSEA; NEUTROPENIA; OVARY CANCER; OVERALL SURVIVAL; PERITONEUM CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; SIDE EFFECT; STEADY STATE; STOMATITIS; SYNCOPE; THROMBOCYTOPENIA; THROMBOSIS; TUMOR BIOPSY;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; COMBINED MODALITY THERAPY; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DNA TOPOISOMERASES, TYPE I, EUKARYOTIC; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; KAPLAN-MEIERS ESTIMATE; MIDDLE AGED; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; TOPOTECAN;

EID: 77949424088     PISSN: 02683369     EISSN: 14765365     Source Type: Journal    
DOI: 10.1038/bmt.2009.181     Document Type: Article

References (41)

1. Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T et al., Cancer statistics 2008. CA Cancer J Clin 2008; 58: 71-96.
2. McGuire WP. Treatment of advanced epithelial ovarian cancer. Clin Oncol 2002; 5: 1-8.
3. Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D et al., Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy- sensitive non-Hodgkin0s lymphoma. N Engl J Med 1995; 333: 1540-1545.
4. Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF et al., A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med 1996; 335: 91-97.
5. Stiff PJ, Bayer R, Kerger C Potkul RK, Malhotra D, Peace DJ et al., High-dose chemotherapy with autologous transplantation for persistent/relapsed ovarian cancer: a multivariate analysis of survival for 100 consecutively treated patients. J Clin Oncol 1997; 15: 1309-1317.
6. Stiff PJ, Veum-Stone J, Lazarus HM, Ayash L, Edwards JR, Keating A et al., High-dose chemotherapy and autologous stem-cell transplantation for ovarian cancer: an autologous blood and marrow transplant registry report. Ann Intern Med 2000; 133: 504-515.
7. Donato ML, Aleman A, Champlin RE, Saliba RM, Wharton JR, Burke TW et al., Analysis of 96 patients with advanced ovarian carcinoma treated with high-dose chemotherapy and autologous stem cell transplantation. Bone Marrow Transplant 2004; 33: 1219-1224.
8. Bengala C, Guarneri V, Ledermann J, Rosti G, Wandt H, Lotz JP et al., High-dose chemotherapy with autologous haemopoietic support for advanced ovarian cancer in first complete remission: retrospective analysis from the solid tumour registry of the Europeon group for blood and marrow transplantation (EBMT). Bone Marrow Transplant 2005; 36: 25-31.
9. Cure H, Battista C, Guastalla J, Fabbro M, Tubiana N, Bourgeois H et al., Phase III randomized trial of high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support as consolidation in patients (pts) with responsive lowburden advanced ovarian cancer (AOC): 5 year follow-up of a GINECO/FNCLCC/SFGM-TC Study. Proc ASCO 2004; 22: 450s (abstract 5006).
10. Möbus V, Wandt H, Frickhofen N, Bengala C, Champion K, Kimmig R et al., Phase III trial of high-dose sequential chemotherapy with peripheral blood stem cell support compared with standard dose chemotherapy for first-line treatment of advanced ovarian cancer: Intergroup trial of the AGO-Ovar/AIO and EBMT. J Clin Oncol 2007; 25: 4187-4193.
11. Sullivan D, Partyka J, Fields K, Goldstein S, Field T, Djubegovic B et al., A phase I study of high-dose topotecan, ifosfamide/MESNA and etoposide (TIME) followed by autologous stem cell rescue in refractory malignancies. Exp Hem 2000; 28(7 Suppl 1): 110 (abstract).
12. Schilder RJ, Gallo JM, Millenson MM, Bookman MA, Weiner LM, Rogatko A et al., Phase I trial of multiple cycles of high-dose carboplatin, paclitaxel, and topotecan with peripheral-blood stem-cell support as front-line therapy. J Clin Oncol 2001; 19: 1183-1194.
13. Park JR, Slattery J, Gooley T, Hawkins D, Lindsley K, Villablanca JG et al., Phase I topotecan preparative regimen for high-risk neuroblastoma, high-grade glioma, and refractory/ recurrent pediatric solid tumors. Med Pediatr Oncol 2000; 35: 719-723.
14. Tiersten A, Selleck M, Smith D, Wertheim I, Kaufman E, Hershman D et al., Phase I/II study of tandem cycles of highdose chemotherapy followed by autologous hematopoietic stem cell support in women with advanced ovarian cancer. Int J Gynecol Cancer 2006; 16: 57-64.
15. Lotz J-P, Pautier P, Selle F, Viens P, Fabbro M, Lokiec F et al., Phase I study of high-dose topotecan with haematopoietic stem cell support in the treatment of ovarian carcinomas: the ITOV 01 protocol. Bone Marrow Transplant 2006; 37: 669-675.
16. Perez-Martinez A, Lassaletta A, Gonzalez-Vicent M, Sevilla J, Angel Diaz M, Madero L et al., High-dose chemotherapy with autologous stem cell rescue for children with high risk and recurrent medulloblastoma and supratentorial primitive neuroectodermal tumors. J Neurooncol 2005; 71: 33-38.
17. Donato ML, Aleman A, Champlin RE, Weber D, Alexanian R, Ippoliti CM et al., High-dose topotecan, melphalan, cyclophosphamide (TMC) with stem cell support: a new regimen for the treatment of multiple myeloma. Leuk Lymphoma 2004; 45: 755-759.
18. Bernbeck B, Bahci S, Meisel R, Troeger A, Schonberger S, Laws HJ et al., Serial intense chemotherapy combining topotecan, etoposide, carboplatin and cyclophosphamide (TECC) followed by autologous hematopoietic stem cell support in patients with high risk soft tissue sarcoma (STS). Klin Padiatr 2007; 219: 318-322.
19. Bookman MA, Malmstrom H, Bolis G, Gordon A, Lassoni A, Krebs JB et al., Topotecan for the treatment of advanced epithelial ovarian cancer: an open-label phase II study in patients treated after prior chemotherapy that contained cisplatin or carboplatin and paclitaxel. J Clin Oncol 1998; 16: 3345-3352.
20. McGuire WP, Blessing JA, Bookman MA, Lentz SS, Dunton CJ. Topotecan has substantial antitumor activity as first-line salvage therapy in platinum-sensitive epithelial ovarian carcinoma: A Gynecologic Oncology Group Study. J Clin Oncol 2000; 18: 1062-1067.
21. Armstrong D. Topotecan dosing guidelines in ovarian cancer: reduction and management of hematologic toxicity. Oncologist 2004; 9: 33-42.
22. Kaufmann S, Peereboom D, Buckwalter C, Svingen PA, Grochow LB, Donehower RC et al., Cyototoxic effects of topotecan combined with various anticancer agents in human cancer cell lines. J Natl Cancer Inst 1996; 88: 699-700.
23. Jonsson E, Fridborg H, Nygren P, Larsson R. Synergistic interactions of combinations of topotecan with standard drugs in primary cultures of human tumor cells from patients. Eur J Clin Pharmacol 1998; 54: 509-514.
24. Ma J, Maliepaard M, Nooter K, Boersma AW, Verweij J, Stoter G et al., Synergistic cytotoxicity of cisplatin and topotecan or SN-38 in a panel of eight solid-tumor cell lines in vitro. Cancer Chemother Pharmacol 1998; 41: 307-316.
25. Johnson R, McCabe FL, Yu Y. Combination regimens with topotecan in animal models. Ann Oncol 1992; 3(Suppl 1): 85 (abstract).
26. Antman K, Ayash L, Elias A, Wheeler C, Hunt M, Eder JP et al., A phase II study of high-dose cyclophosphamide, thiotepa, and carboplatin with autologous marrow support in women with measurable advanced breast cancer responding to standard-dose therapy. J Clin Oncol 1992; 10: 102-110.
27. Kaufmann SH, Karp JE, Letendre L, Kottke TJ, Safgren SL, Greer J et al., Phase I and pharmacological study of infusional topotecan and carboplatin in relapsed and refractory acute leukemia. Clin Cancer Res 2005; 11: 6641-6649.
28. Creemers GJ, Gerrits CJ, Schellens JH, Planting AS, van der Burg ME, van Beurden VM et al., Phase II and pharmacologic study of topotecan administered as a 21-day continuous infusion to patients with colorectal cancer. J Clin Oncol 1996; 14: 2540-2545.
29. Herben VM, ten Bokkel Huinink WW, Schot ME, Hudson I, Beijnen JH. Continuous infusion of low-dose topotecan: pharmacokinetics and pharmacodynamics during a phase II study in patients with small cell lung cancer. Anticancer Drugs 1998; 9: 411-418.
30. Pizao P, Smitskamp-Wilms E, Van Ark-Otte J, Beijnen JH, Peters GJ, Pinedo HM et al., Antiproliferative activity of the topoisomerase I inhibitors topotecan and camptothecin, on sub- and postconfluent tumor cell cultures. Biochemical Pharmacol 1994; 48: 1145-1154.
31. Li T, Liu L. Tumor cell death induced by topoisomerasetargeting drugs. Ann Rev Pharmacol and Toxicol 2001; 41: 53-77.
32. Nitiss J, Rose A, Sykes K, Harris J, Zhou J. Using yeast to understand drugs that target topoisomerases. Ann NY Acad Sci 1996; 803: 32-43.
33. van Waardenburg R, de Jong L, van Eijndhoven MAJ, Verseyden C, Pluim D, Jansen LET et al., Platinated DNA adducts enhance poisoning of DNA topoisomerase I by camptothecin. J Biol Chem 2004; 279: 54502-54509.
34. Walton M, Whysong D, O'Connor P, Hockenbery D, Korsmeyer SJ, Kohn KW. Constitutive expression of human bcl-2 modulates nitrogen mustard and camptothecin induced apoptosis. Cancer Res 1993; 53: 1583-1861.
35. Williams J, Lucas P, Griffith K, Choi M, Fogoros S, Hu YY et al., Expression of bcl-xL in ovarian carcinoma is associated with chemoresistance and recurrent disease. Gynecol Oncol 2005; 96: 287-295.
36. Cook S, Penson R, Duska L, Nikrui N, Goodman A, Fuller A et al., Efficacy and hematologic toxicity of salvage chemotherapy following stem cell-supported high-dose chemotherapy in women with recurrent ovarian cancer. Gynecol Oncol 2000; 77: 48-54.
37. Rowinsky E, Kaufmann S, Baker S, Grochow LB, Chen TL, Peereboom D et al., Sequences of topotecan and cisplatin: phase I, pharmacologic, and in vitro studies to examine sequence dependence. J Clin Oncol 1996; 14: 3074-3084.
38. Pourquier P, Waltman J, Urasaki Y, Loktionova NA, Pegg AE, Nitiss JL et al., Topoisomerase I-mediated cytotoxicity of N-methyl-N0-nitro-N- nitrosoguanidine: trapping of topoisomerase I by the O6-methylguanine. Cancer Res 2001; 61: 53-58.
39. Cornaratti M, Capranico G, Bohm S, Oriana S, Spatti GB, Mariani L et al., Gene expression of DNA topoisomerases II I alpha and II beta and response to cisplatin-based chemotherapy in advanced ovarian carcinoma. Int J Cancer 1996; 67: 479-484.
40. Materna V, Pleger J, Hoffmann U, Lage H. RNA expression of MDR1/P-glycoprotein, DNA-topoisomerase I, and MRP2 in ovarian carcinoma patients: correlation with chemotherapeutic response. Gynecol Oncol 2004; 94: 152-160.
41. Schilder RJ, Brady MF, Spriggs D, Shea T. Pilot evaluation of high-dose carboplatin and paclitaxel followed by high-dose melphalan supported by peripheral blood stem cells in previously untreated advanced ovarian cancer: a Gynecologic Oncology Group study. Gynecol Oncol 2003; 88: 3-8.