Dose finding study for combination treatment with topotecan and gemcitabine of patients with recurrent ovarian cancer after failure of first-line chemotherapy with paclitaxel and platinum

Onkologie

Volumn 27, Issue 1, 2004, Pages 58-64

  Sehouli, J ^a,b   Stengel, D ^c   Oskay, G ^a   Blohmer, J ^b   Kaubitzsch, S ^d   Lichtenegger, W ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b HUMBOLDT UNIVERSITY   (Germany)

^c Klin F Unfall W   (Germany)

^d GLAXOSMITHKLINE   (Germany)

Author keywords

Chemotherapy; Gemcitabine; Ovarian cancer; Topotecan

Indexed keywords

CARBOPLATIN; CYTOKINE; GEMCITABINE; PACLITAXEL; PLATINUM DERIVATIVE; TOPOTECAN;

ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER RECURRENCE; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REGIMEN; DRUG RESPONSE; DRUG SCREENING; DRUG TOLERABILITY; FEASIBILITY STUDY; FEBRILE NEUTROPENIA; FEMALE; HISTOPATHOLOGY; HUMAN; INFECTION; LEUKOPENIA; MALE; MAXIMUM TOLERATED DOSE; MONOTHERAPY; MYCOSIS; NAUSEA; NEUROTOXICITY; OVARY CANCER; PRIMARY HEALTH CARE; RECURRENT CANCER; SKIN TOXICITY; STOMATITIS; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; TOXICITY; TREATMENT FAILURE; VOMITING;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; OVARIAN NEOPLASMS; PACLITAXEL; RETREATMENT; TOPOTECAN; TREATMENT FAILURE;

EID: 1542513231     PISSN: 0378584X     EISSN: None     Source Type: Journal    
DOI: 10.1159/000075607     Document Type: Article

References (43)

1. Ferlay JF, Pisani P, Parkin DM: GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0. IARC CancerBase No. 5. Lyon, IARCPress, 2001.
2. Berek JS, Bertelsen K, du Bois A, Brady MF, Carmichael J, Eisenhauer EA, Gore M, Grenman S, Hamilton TC, Hansen SW, Harper PG, Horvath G, Kaye SB, Lück HJ, Lund B: Advanced epithelial ovarian cancer: 1998 consensus statements. Ann Oncol 1999;10:87-92.
3. Lichtenegger W, Sehouli J, Buchmann E: Operative results after primary and secondary debulking-operations in advanced ovarian cancer. J Obstet Gyn Research 1998;24:447-451.
4. Du Bois A, Lueck HJ, Bauknecht T: First-line chemotherapy in advanced ovarian cancer: State of the art and future aspects. Onkologie 1999;22:269-280.
5. Lichtenegger W: Die Rolle der Anthrazykline beim Ovarialkarzinom. Onkologie 2000;23(Suppl 2):28-30.
6. Meier W: Current study concepts for refractory ovarian carcinoma. Onkologie 1998;21(Suppl 4):10-12.
7. Lück HJ, Scholz U, Petry KU, Böhmer G, Kühnle H: Importance of topotecan in the therapy of ovarian carcinoma, today and tomorrow. Onkologie 1998;21(Suppl 4):6-9.
8. Möbus V, Pfaff, PN, Kreienberg R: Topotecan (hycamtin) in the therapy of recurrent ovarian carcinoma. Onkologie 1998;21(Suppl 4):2-5.
9. Conte PF, Gadducci A, Cianci C: Second-line treatment and consolidation therapies in advanced ovarian cancer. Int J Gynecol Cancer 2001;11(Suppl 1): 52-56.
10. Knopf K, Brown M, Kohn EC: Lack of improvement in survival in patients with relapsed or refractory epithelial ovarian cancer, 1980-1997, Proc ASCO 1998; Abstr 1385.
11. Markman M, Rothman R, Hakes T, Reichman B, Hoskins W, Rubin S, Jones W, Almadrones L, Lewis JL Jr: Second-line platinum therapy in patients with ovarian cancer previously treated with cisplatin. J Clin Oncol 1991;9:389-393.
12. Walle U, Sehouli J, Stengel D, Klapp C, Koensgen D, Lichtenegger W, Porzsolt F, on behalf of the NOGGO Study Group: Developement of a symptom-check-list for patients with advanced ovarian cancer. Results from a phase I and II clinical trial. Proc ASCO 2001; Abstr 2531.
13. Bookman MA, Malmstrom H, Bolis G, Gordon A, Lissoni A, Krebs JB, Fields SZ: 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.
14. Bookman MA: Developmental chemotherapy in advanced ovarian cancer: Incorporation of topoisomerase-I inhibitors and perspective of the Gynecologic Oncology Group. Int J Gynecol Cancer 2001;11(Suppl 1):42-51.
15. Del Bino G, Lassota P, Darzynkiewicz Z. The S-phase cytotoxicity of camphothecin. Exp Cell Res 1991;193:27-35.
16. Creemers GJ, Bolis G, Gore M, Scarfone G, Lacave AJ, Guastalla JP, Despax R, Favalli G, Kreinberg R, Van Belle S, Hudson I, Verweij J, Ten Bokkel Huinink WW: Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: Results of a large European phase II study. J Clin Oncol 1996;14:3056-3061.
17. Kudelka AP, Tresukosol D, Edwards CL, Freedman RS, Levenback C, Chantarawiroj P, Gonzalez de Leon C, Kim EE, Madden T, Wallin B, Hord M, Verschraegen C, Raber M, Kavanagh JJ: Phase II study of intravenous topotecan as a 5-day infusion for refractory epithelial ovarian carcinoma. J Clin Oncol 1996;14:1552-1557.
18. Ten Bokkel Huinink W, Gore M, Carmichael J, Gordon A, Malfetano J, Hudson I, Broom C, Scarabelli C, Davidson N, Spanczynski M, Bolis G, Malmstrom H, Coleman R, Fields SC, Heron JF: Topotecan versus paclitaxel for the tretment of recurrent epithelial ovarian cancer. J Clin Oncol 1997;15:2183-2193.
19. Gore M, ten Bokkel Huinink W, Carmichael J, Gordon A, Davidson N, Coleman R, Spaczynski M, Heron JF, Bolis G, Malmstrom H, Malfetano J, Scarabelli C, Vennin P, Ross G, Fields SZ: Clinical evidence for topotecan-paclitaxel non-cross-resistance in ovarian cancer. J Clin Oncol 2001;19:1893-1900.
20. Von Hoff DD, Burris HA, Eckardt J: Preclinical and phase I trials of topoisomerase I inhibitors. Cancer Chemother Pharmacol 1994;34(Suppl):S41-S45.
21. Ganem G, Gladieff L, Guastalla JP: Sequential topotecan and etoposid in pretreated ovarian cancer: A GINECO phase II study. Proc ASCO 1998; Abstr 1371.
22. Madhusudan S, Deplanque G, Levitt NA: A Phase I study of sequential topotecan and infusional etoposide phosphate in recurrent ovarian cancer. Proc ASCO 2001; Abstr 871.
23. Rowinsky EK, Kaufmann SH, Baker SD, Grochow LB, Chen TL, Pereboom D, Bowling MK, Sartorius SE, Ettinger DS, Forastiere AA, Donehower RS: Sequences of topotecan and cisplatin: Phase I, pharmacologic and in vitro studies to examine sequence dependence. J Clin Oncol 1996;14:3074-3084.
24. Sehouli J, Lichtenegger W, Schönborn J: Phase I trial of topotecan in combination with gemcitabine in platinum and paclitaxel refractory ovarian cancer. Proc ASCO 1999; Abstr 1482.
25. Vannetzel JM, Fabbro M, Weber B: Topotecan (T) and cyclophosphamide (Cy) in second line treatment of advanced ovarian cancer (AOC): A GINECO phase II trial. Proc ASCO 2001; Abstr 811.
26. Hertel L, Boder GB, Kroin JS: Evaluation of the antitumor activity of gemcitabine. Cancer Res 1990;50:4417-4422.
27. Morant R: Phase II study: Gemcitabine in refractory metastatic prostatic carcinoma. Proc ASCO 1997; Abstr 1109.
28. Hansen SW, Anderson H, Boman K, Hansen ML: Gemcitabine, carboplatin, and paclitaxel (GCP) as first-line treatment of ovarian cancer FIGO stages IIB-IV. Proc ASCO 1999; Abstr 1395.
29. Lund B, Hensen OP, Theilade K: Phase II study of gemcitabine (2'2'-difluorodeooxycytidine) in previously treated ovarian cancer patients. J Natl Cancer Inst 1994;86:1530-1533.
30. Shapiro JD, Millward MJ, Rischin D: Activity of gemcitabine in patients with advanced ovarian cancer: Responses seen following platinum and paclitaxel. Gynecol Oncol 1996;63:89-93.
31. Von Minckwitz G, Bauknecht T, Visseren-Grul CM, Neijt JP: Phase II study of gemcitabine in ovarian cancer. Ann Oncol 1999;10:853-855.
32. Coenen M, Berteloot P, Amant F, Vangramberen M, Vergote I: Gemcitabine in platin-paclitaxel resistant ovarian carcinoma. Proc ASCO. 2000; Abstr 1603.
33. Faries D: Practical modifications of the continual reassessment method for phase 1 cancer clinical trials. J Biopharm Stat 1994;4:147-164.
34. Perry MC: National Cancer Institute common toxicity criteria; in Perry MC (ed): The Chemotherapy Source Book, vol 11. Baltimore, Williams & Wilkins, 1990, pp 33-40.
35. O'Reilly S, Armstrong DK, Grochow LB: Life-threatening myelosupression in patients with occult renal impairment receiving topotecan. Gynecol Oncol 1997;67:329-330.
36. Distefano M, Ferlini C, De-Vincenzo R, Gaggini C, Manusco S, Scambia G: Antagonistic effect of the combination of gemcitabine/topotecan in ovarian cancer cells. Oncol Res 2001;12:355-359.
37. Cole JL, Rinaldi DA, Lormand NA: Phase I trial of topotecan and gemcitabine for patients with previously treated, advanced non-small cell cancer. Proc ASCO 1999; Abstr 1930.
38. Laufmann LR, Spiiridonidis CH, Jones JJ: Gemcitabine and topotecan - a phase I trial. Proc ASCO 1999; Abstr 837.
39. Sun W, Stevenson JP, Gallagher M, Giantonio B, Algazy K, Haller D, Vaughn D, Raskay BJ, O'Dwyer PJ: A phase I trial of topotecan and gemcitabine administered weekly for 3 consecutive weeks to patients with advanced tumors. Cancer 2001;92:414-419.
40. Greggi S, Salerno MG, D'Agostino G, Ferrandina G, Lorusso D, Manzione L, Mancuso S, Scambia G: Topotecan and gemcitabine in platinum/paclitaxel- resistant ovarian cancer. Oncology 2001;60:19-23.
41. Dabrow MB, Gilman PB, Meyer TJ: Combined therapy with topotecan and gemcitabine in patients with inoperable or metastatic NSCLC. Proc ASCO 1999; Abstr 1930.
42. Sorensen M, Jensen PB, Herrstedt J, Hirsch FR, Hansen HH:A dose escalating study of topotecan preceding cisplatin in previously untreated patients with small-cell lung cancer. Ann Oncol 2000;11:829-835.
43. Sehouli J, Stengel D, Oskay G, Camara O, Hindenburg HJ, Klare P, Blohmer J, Heinrich G, Elling D, Ledwon P, Lichtenegger W: A phase II study of topotecan plus gemcitabine in the treatment of patients with relapsed ovarian cancer after failure of first-line chemotherapy. Ann Oncol 2002;13:1749-1755.