Phase I and pharmacologic study of high doses of the topoisomerase I inhibitor topotecan with granulocyte colony-stimulating factor in patients with solid tumors

Journal of Clinical Oncology

Volumn 14, Issue 4, 1996, Pages 1224-1235

  Rowinsky, E K ^a   Grochow, L B ^a   Sartorius, S E ^a   Bowling, M K ^a   Kaufmann, S H ^a   Peereboom, D ^a   Donehower, R C ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR; TOPOTECAN;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BONE MARROW SUPPRESSION; CANCER IMMUNOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG CLEARANCE; DRUG MEGADOSE; ENZYME INHIBITION; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; MAXIMUM ALLOWABLE CONCENTRATION; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; SUBCUTANEOUS DRUG ADMINISTRATION; THROMBOCYTOPENIA;

EID: 0029883729     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.4.1224     Document Type: Article

References (56)

1. Slichenmyer WJ, Rowinsky EK, Donehower RC, et al: The current status of camptothecin analogues as antitumor agents. J Natl Cancer Inst 85:271-291, 1993
2. Kingsbury WD, Boehm JC, Jakas DR, et al: Synthesis of water-soluble (aminoalkyl) camptothecin analogues: Inhibition of topoisomerase I and antitumor activity. J Med Chem 34:98-107, 1991
3. Hertzberg RP, Caranfa MJ, Holden KG, et al: Modification of the hydroxy lactone ring of camptothecin: Inhibition of mammalian topoisomerase I and biological activity. J Med Chem 32:715-717, 1989
4. Kantajarian HM, Beran M, Ellis A, et al: Phase I study of topotecan, a new topoisomerase I inhibitor, in patients with refractory or relapsed leukemia. Blood 81:1146-1151, 1993
5. Rowinsky EK, Adjei A, Donehower RC, et al: A phase I and pharmacodynamic study of the topoisomerase I inhibitor topotecan in patients with refractory acute leukemia. J Clin Oncol 12:2193-2203, 1994
6. Schiller JH, Kim K, Johnson D: Phase II study of topotecan in extensive stage small cell lung cancer. Proc Am Soc Clin Oncol 13:330, 1994 (abstr)
7. Ardizzoni A, Hansen H, Dombernowsky P, et al: Phase II study of topotecan in pretreated small cell lung cancer (sclc). Proc Am Soc Clin Oncol 13:336, 1994 (abstr)
8. Kudelka A, Edwards C, Freedman R, et al: An open phase II study to evaluate the efficacy and toxicity of topotecan administered intravenously as 5 daily infusions every 21 days to women with advanced epithelial ovarian carcinoma. Proc Am Soc Clin Oncol 12:259, 1993 (abstr)
9. Armstrong D, Rowinsky E, Donehower RC, et al: Phase II study of topotecan as salvage therapy in epithelial ovarian cancer. Proc Am Soc Clin Oncol 14:275, 1995 (abstr)
10. Eisenhauer EA, Wainman G, Boos G, et al: Phase II trials of topotecan in patients (pts) with malignant glioma and soft tissue sarcoma. Proc Am Soc Clin Oncol 13:175, 1994 (abstr)
11. Houghton PJ, Cheshire PJ, Hallman JC, et al: Therapeutic efficacy of the topoisomerase I inhibitor 7-ethyl-10-(4-[piperidino]-1-piperidon)-carbonyl-oxy-campthotecin against human tumor xenografts: Lack of cross-resistance in vivo in tumors with acquired resistnace to the topoisomerase I inhibitor 9-dimethylaminomethyl-10-hydroxycampthothecin. Cancer Res 53:2823-2829, 1993
12. Topotecan, NSC 609669 Investigator Brochure. King of Prussia, PA, SmithKline Beecham Pharmaceuticals, June 1994
13. Rowinsky E, Grochow L, Hendricks C, et al: Phase I and pharmacologic study of topotecan (SK&F 104864): A novel topoisomerase I inhibitor. J Clin Oncol 10:647-656, 1992
14. van Warmerdam LJC, Verweij J, Schellens JHM, et al: Pharmacokinetics and pharmacodynamics of topotecan administered daily for 5 days every 3 weeks. Cancer Chemother Pharmacol 35:237-245, 1995
15. Saltz L, Sirott M, Young C, et al: Phase I clinical and pharmacology study of topotecan given daily for 5 consecutive days to patients with advanced solid tumors, with attempt at dose intensification using recombinant granulocyte colony-stimulating factor. J Natl Cancer Inst 85:1499-1507, 1993
16. Hochster H, Liebes L, Speyer J, et al: Phase I trial of low-dose continuous topotecan infusion in patients with cancer: An active and well tolerated regimen. J Clin Oncol 12:553-559, 1994
17. Creemers GJ, Schellens JHM, Planting AST, et al: Cumulative myelosuppression of topotecan (T) administered as a 21-day continuous infusion in patients with colorectal cancer. Proc Am Soc Clin Oncol 14:167, 1995 (abstr)
18. Sugarman SM, Ajani JA, Daugherty K, et al: A phase II trial of topotecan (TPT) for the treatment of advanced, measurable colorectal cancer. Proc Am Proc Clin Oncol 13:225, 1994 (abstr)
19. Hendricks CB, Rowinsky EK, Grochow LB, et al: Effect of P-glycoprotein expression on accumulation and cytotoxicity of topotecan (SK&F 104864), a new camptothecin analog. Cancer Res 52:2268-2278, 1992
20. Chen AY, Yu C, Potmesil M, Wall ME, et al: Camptothecin overcomes mdrl-mediated resistance in human KB carcinoma cells. Cancer Res 51:6039-6044, 1991
21. Mattern MR, Hofmann GA, Polsky RM, et al: In vitro and in vivo effects of clinically important camptothecin analogues in multidrug-resistant cells. Oncology Res 5:467-474, 1993
22. Cancer Therapy Evaluation Program: Common toxicity criteria, in NCI Decision of Cancer Treatment Guidelines for Reporting of Adverse Drug Reactions. Bethesda, MD, National Cancer Institute, 1989, pp 6-9
23. Grochow LB, Rowinsky EK, Johnson R, et al: Pharmacokinetics and pharmacodynamics of topotecan. Drug Met Dispos 20:706-712, 1992
24. Goldstein A, Aronow L, Kalman S: Principles of Drug Action. The Basics of Pharmacology, New York, NY, Wiley, 1974, pp 83-95
25. Pratt CB, Stewart C, Santana VM, et al: Phase I study of topotecan for pediatric patients with malignant solid tumors. J Clin Oncol 12:539-543, 1994
26. Gottlieb JA, Guarino AM, Call JB, et al: Preliminary pharmacologic and clinical evaluation of camptothecin sodium (NSC-100880). Cancer Chemother Rep 54:461-470, 1970
27. Muggia FM, Creaven PJ, Hansen HH, et al: Phase I clinical trial of weekly and daily treatment with camptothecin (NSC-100880): Correlation with preclinical studies. Cancer Chemother Rep 56:515-521, 1972
28. Moertel CG, Schutt AJ, Reitmeir RJ, et al: Phase II study of camptothecin (NSC-100880) in the treatment of advanced gastrointestinal cancer. Cancer Chemother Rep 56:95-101, 1972
29. Gottlieb JA, Luce JK: Treatment of malignant melanoma with camptothecin (NSC-100880). Cancer Chemother Rep 56:103-105, 1972
30. Creaven PJ, Allen LM, Muggia FM: Plasma camptothecin (NSC-100880) levels during a 5-day course of treatment: Relation to dose and toxicity. Cancer Chemother Rep 56:573-578, 1972
31. Negoro S, Fukuoka M, Masuda N, et al: Phase I study of weekly intravenous infusions of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small cell lung cancer. J Natl Cancer Inst 83:1164-1168, 1991
32. Ohe Y, Saski Y, Shinkai T, et al: Phase I and pharmacokinetic study of CPT-11 with 5-day continuous infusion. J Natl Cancer Inst 12:972-974, 1992
33. Rothenberg ML, Kuhn J, Burris HA, et al: A phase I and pharmacokinetic trial of CPT-11 in patients with refractory solid tumors. J Clin Oncol 11:2194-2204, 1993
34. Rowinsky EK, Grochow LB, Ettinger DS, et al: Phase I and pharmacologic study of the novel topoisomerase I inhibitor CPT-11 administered as a 90 minute infusion every 3 weeks. Cancer Res 54:427-436, 1994
35. Gandia D, Abigerges D, Armand JP, et al. CPT-11-induced cholinergic effects in cancer patients. J Clin Oncol 11:196-197, 1993
36. Abigerges D, Chabot GG, Armand J-P, et al: Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol 13:210-221, 1995
37. Rubin E, Wood V, Bharti A, et al: A phase I and pharmacokinetic study of a new camptothecin derivative, 9-aminocamptothecin. Clin Cancer Res 1:269-276, 1995
38. Dahut W, Brillhart N, Takimoto C, et al: A phase I trial of 9-aminocamptothecin (9-AC) in adult patients with solid tumors. Proc Am Soc Clin Oncol 13:138, 1994 (abstr)
39. Tsuruo T, Matsuzaki T, Matsushita M, et al: Antitumor activity of CPT-11, a new derivative of camptothecin, against pleotropic drug resistant tumors in vitro and in vivo. Cancer Chemother Pharmacol 21:71-74, 1988
40. Chang JY, Dethlefsen LA, Barley LR, et al: Characterization of camptothecin-resistant Chinese hamster lung cells. Biochem Pharm 43:2443-2452, 1992
41. Mattern MR, Hofmann GA, Polsky RM, et al: Cross resistance of mdr, P-glycoprotein overexpressing CHO cells to camptothecin analogues. Proc Am Assoc Cancer Res 34:424, 1993 (abstr)
42. Moore MA, Stolfi RL, Martin DS: Hematologic effects of interleukin-1beta, granulocyte colony-stimulating factor, and granulocyte-macrophage colony-stimulating factor in tumor-bearing mice treated with fluorouracil. J Natl Cancer Inst 82:1031-1037, 1990
43. Meropol NJ, Miller LL, Korn EL, et al: Severe myelosuppression resulting from concurrent administration of granulocyte colony-stimulating factor and cytotoxic chemotherapy. J Natl Cancer Inst 84:1201-1203, 1992
44. Kaplan LD, Kahn JO, Crowe S, et al: Clinical and virologic effects of recombinant human granulocyte-macrophage colony-stimulating factor in patients receiving chemotherapy for human immunodeficiency virus-associated non-Hodgkin's lymphoma: Results of a randomized trial. J Clin Oncol 9:929-940, 1991
45. Osborne CK, Sutherland MC, Neidhart JA, Ravdin PM, Abeloff MA: Failure of GM-CSF to permit dose-escalation in an every other week dose-intensive regimen for advanced breast cancer. Ann Oncol 5:43-47, 1994
46. Clark DA, Neidhart JA: Granulocyte-macrophage colony-stimulating factor with dose-intensified treatment of cancer. Semin Hematol 29:27-32, 1992 (suppl 3)
47. Hsiang Y-H, Hertzberg R, Hecht S, et al: Camptothecin induces protein-linked DNA breaks via mamalian DNA topoisomerase I. J Biol Chem 260:14873-14878, 1987
48. Hsiang Y-H, Liu LF: Identification of mamalian DNA topoisomerase I as an intracellular target of the anticancer drug camptothecin. Cancer Res 48:1722-1726, 1988
49. Eng W-K, Faucette L, Johnson RK, et al: Evidence that DNA topoisomerase I is necessary for the cytotoxic effects of camptothecin. Mol Pharmacol 34:755-760, 1988
50. Jaxel C, Kohn KW, Wani MC, et al: Structure-activity study of the actions of camptothecin derivatives on mammalian topoisomerase I: Evidence for a specific receptor site and a relation to antitumor activity. Cancer Res 49:1465-1469, 1989
51. Tsao Y-P, Russo A, Nyamuswa G, et al: Interaction between replication forks and topoisomerase I-DNA cleavable complexes: Studies in a cell-free SV-40 DNA replication system. Cancer Res 5:5908-5914, 1993
52. Kaufmann SH, Charron M, Burke PJ, Karp JE: Changes in topoisomerase I levels and localization during myeloid maturation in vitro and in vivo. Cancer Res 55:1255-1260, 1995
53. Pettergell R, Morgenstern GR, Woll PJ, et al: Peripheral blood progenitor cell transplantation in lymphoma and leukemia using a single apheresis. Blood 82:3770-3777, 1993
54. Gale RP, Henon P, Juttner C: Blood stem cell transplants come of age. Bone Marrow Transplant 9:151-155, 1992
55. Moore MAS: Clinical implications of positive and negative hematopoietic stem cell regulators. Blood 78:1-19, 1991
56. Moore MAS: Does stem cell exhaustion result from combining hematopoietic growth factors with chemotherapy? If so, how do we prevent it? Blood 80:3-7, 1992