Phase I study of escalating doses of mitoxantrone and paclitaxel with granulocyte-macrophage colony stimulating factor support

Cancer

Volumn 77, Issue 11, 1996, Pages 2308-2312

  Fleming, Gini F ^a,b   Janisch, Linda ^a   Vogelzang, Nicholas J ^a   Vokes, Everett E ^a   Ratain, Mark J ^a  

^a UNIVERSITY OF CHICAGO   (United States)

^b UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

Author keywords

breast cancer; granulocyte macrophage colony stimulating factor; mitoxantrone; paclitaxel; Phase I

Indexed keywords

CIMETIDINE; DEXAMETHASONE; DIPHENHYDRAMINE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; MITOXANTRONE; PACLITAXEL; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR;

ADULT; AGED; ARTICLE; BLADDER CANCER; BLOOD CELL COUNT; BREAST CANCER; CLINICAL ARTICLE; CLINICAL TRIAL; COLON CANCER; DOSE CALCULATION; ESOPHAGITIS; ESOPHAGUS CANCER; FATIGUE; FEMALE; HEAD AND NECK CANCER; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; LUNG CANCER; MALE; MESOTHELIOMA; MYALGIA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; SOLID TUMOR; SUBCUTANEOUS DRUG ADMINISTRATION; TESTIS CANCER;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; FEMALE; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; MALE; MIDDLE AGED; MITOXANTRONE; NEOPLASMS; NEUTROPENIA; PACLITAXEL; RECOMBINANT PROTEINS; TREATMENT FAILURE;

EID: 0030015106     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0142(19960601)77:11<2308::AID-CNCR19>3.0.CO;2-0     Document Type: Article

References (19)

1. Munzone E, Gianni L, Capri G, Villani F, Fulfaro E, Tarenz E, et al. Cardiac function in breast cancer patients (PTS) given paclitaxel (P) by 3-H infusion and previous or concomitant doxorubicin (D). Proc Am Soc Clin Oncol 1995; 14:128.
2. Henderson IC, Allegra JC, Woodcock T, Wolff S, Bryan S, Cartwright K, et al. Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer. J Clin Oncol 1989; 7:560-71.
3. Neidhardt IA, Gochnour D, Roach R, Hoth D, Young D. A comparison of mitoxantrone and doxorubicin in breast cancer. J Clin Oncol 1986; 4:672-7.
4. Posner LE, Dukart G, Goldberg J, Bernstein T, Cartwright K. Mitoxantrone: an overview of safety and toxicity. Invest New Drugs 1985; 3:123-32.
5. Alberts DS, Young L, Mason N, Salmon SE. In vitro evaluation of anticancer drugs against ovarian cancer at concentrations achievable by intraperitoneal administration. Semin Oncol 1985; 12(Suppl 4):38-42.
6. Stiff PI, McKenzie RS, Alberts DS, Sosman JA, Dolan JR, Rad N, et al. Phase I clinical and pharmacokinetic study of high-dose mitoxantrone combined with carboplatin, cyclophosphamide, and autologous bone marrow rescue: high response rate for refractory ovarian carcinoma. J Clin Oncol 1994 12:176-83.
7. Feldman EJ, Alberts DS, Arlin Z, Ahmed T, Mittleman A, Baskind P, et al. Phase I clinical and pharmacokinetic evaluation of high-dose mitoxantrone in combination with cytarabine in patients with acute leukemia. J Clin Oncol 1993; 11:2002-9.
8. Markman M, Gerge M, Hakes T, Reichman B, Hoskins W, Rubin S, et al. Phase 2 trial of intraperitoneal mitoxantrone in the management of refractory ovarian carcinoma. J Clin Oncol 1990; 8:146-50.
9. O'Reilly SE, Gelmon KA, Onetto N, Parente I, Rubinger M, Page RA, et al. Phase I trial of recombinant human granulocyte-macrophage colony-stimulating factor derived from yeast in patients with breast cancer receiving cyclophosphamide, doxorubicin, and fluorouracil. J Clin Oncol 1993; 11:2411-6.
10. Schiller JH, Storer B, Arzoomanian R, Tutsch K, Alberti D, Spriggs D. Phase I trial of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) in patients with advanced solid malignancies. Invest New Drugs 1993; 11:291-300.
11. Demetri GD, Horowitz J, McGuire BW, Merica EA, Howard G, Henderson IC. Dose-intensification of mitoxantrone with adjunctive G-CSF (r-metHu-G-CSF) in patients with advanced breast cancer: a phase I trial. ProcAm Soc Clin Oncol 1992; 11:137.
12. Capizzi RL. Mitoxantrone (Novantrone): clinical pharmacology and investigation in non-Hodgkin's lymphomas. Oncology Times 1989; 11(Suppl):3-9.
13. Holmes FA. Combination chemotherapy with taxol (paclitaxel) in metastatic breast cancer. Ann Oncol 1994; 5(Suppl 6):23S-7S.
14. Rosenthal CJ, Ibrahim A, Rambhia H, Bellina D, DiPillo F. Paclitaxel (Taxol)-mitoxantrone salvage therapy in metastatic carcinoma of the breast-phase I/II study. Proc Am Soc Clin Oncol 1994; 14:92.
15. Gianni L, Locatelli A, Vigano L, Capri G, Giani A, Munzone E, et al. Order of administration and pharmacokinetics of paclitaxel (P) by 3 H infusion and doxorubicin (D) by IV bolus. Proc Am Soc Clin Oncol 1995; 14:169.
16. Gianni L, Straneo M, Capri G, Villani F, Munzone E, Bonadonna G. Optimal dose and sequence finding study of paclitaxel (P) by 3 H infusion combined with bolus doxorubicin (D) in untreated metastatic breast cancer patients (PTS). ProcAm Soc Clin Oncol 1994; 13:74.
17. Lieschke GJ, Burgess AW. Granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor. N Engl J Med 1992; 327:28-35 (first of two parts) and 99-106 (second of two parts).
18. Rowinsky EK, Donehower RC. Paclitaxel (Taxol). N Engl J Med 332:1004-14.
19. Bajetta E, Buzzoni R, Valagussa P, Bonadonna G. Mitoxantrone: an active agent in refractory non-Hodgkin's lymphomas. Am J Clin Oncol 1988; 11:100-3.