Fixed-dose rate gemcitabine plus carboplatin in relapsed, platinum-sensitive ovarian cancer patients: Results of a three-arm Phase I study

Gynecologic Oncology

Volumn 115, Issue 3, 2009, Pages 389-395

  Alvarez, Ronald D ^a   Mannel, Robert ^b   García, Agustin A ^c   Gallion, Holly H ^d   Lucci III, Joseph ^e   Kilgore, Larry C ^a   Numnum, Thomas M ^f   Zou, Sharon Xiaohan ^g   Orlando, Mauro ^h   Tai, Datchen F ^g  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^d UNIVERSITY OF PITTSBURGH   (United States)

^e UNIVERSITY OF MIAMI   (United States)

^f Tennessee Oncology   (United States)

^g Lilly USA   (United States)

^h ELI LILLY AND COMPANY   (United States)

Author keywords

Carboplatin; Fixed dose rate; Gemcitabine; Ovarian cancer; Phase I; Platinum sensitive

Indexed keywords

CARBOPLATIN; GEMCITABINE; PLATINUM DERIVATIVE;

ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER RELAPSE; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG SENSITIVITY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MAXIMUM TOLERATED DOSE; MEASUREMENT; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; NAUSEA; NEUROPATHY; NEUTROPENIA; OVARY CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; COHORT STUDIES; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MIDDLE AGED; OVARIAN NEOPLASMS;

EID: 70350569388     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2009.09.013     Document Type: Article

References (32)

1. Ozols R.F. Systemic therapy for ovarian cancer: current status and new treatments. Semin. Oncol. 33 2 Suppl 6 (2006) S3-S11
2. NCCN Clinical Practice Guidelines in Oncology. Ovarian Cancer. V.1.2009. Available at http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. (Accessed 5 June 2009).
3. Hui Y.F., and Reitz J. Gemcitabine: a cytidine analogue active against solid tumors. Am. J. Health-Syst. Pharm. 54 (1997) 162-170
4. Lund B., Hansen O.P., Theilade K., Hansen M., and Neijt J.P. Phase II study of gemcitabine (2′,2′-difluorodeoxycytidine) in previously treated ovarian cancer patients. J. Natl. Cancer Inst. 86 (1994) 1530-1533
5. Shapiro J.D., Millward M.J., Rischin D., Michael M., Walcher V., Francis P.A., et al. Activity of gemcitabine in patients with advanced ovarian cancer: responses seen following platinum and paclitaxel. Gynecol. Oncol. 63 (1996) 89-93
6. Veltkamp S.A., Beijnen J.H., and Schellens J.H. Prolonged versus standard gemcitabine infusion: translation of molecular pharmacology to new treatment strategy. Oncologist 13 (2008) 261-276
7. Guan Z., Wang Y., Maoleekoonpairoj S., Chen Z., Kim W.S., Ratanatharathorn V., et al. Prospective randomised phase II study of gemcitabine at standard or fixed dose rate schedule in unresectable hepatocellular carcinoma. Br. J. Cancer 89 (2003) 1865-1869
8. Tempero M., Plunkett W., Ruiz Van Haperen V., Hainsworth J., Hochster H., Lenzi R., et al. Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J. Clin. Oncol. 21 (2003) 3402-3408
9. Soo R.A., Wang L.Z., Tham L.S., Yong W.P., Boyer M., Lim H.L., et al. A multicentre randomised phase II study of carboplatin in combination with gemcitabine at standard rate or fixed dose rate infusion in patients with advanced stage non-small-cell lung cancer. Ann. Oncol. 17 (2006) 1128-1133
10. Cappuzzo F., Novello S., De Marinis F., Selvaggi G., Scagliotti G.V., Barbieri F., et al. A randomized phase II trial evaluating standard (50 mg/min) versus low (10 mg/min) infusion duration of gemcitabine as first-line treatment in advanced non-small-cell lung cancer patients who are not eligible for platinum-based chemotherapy. Lung Cancer 52 (2006) 319-325
11. Ceribelli A., Gridelli C., De Marinis F., Fabi A., Gamucci T., Cortesi E., et al. Prolonged gemcitabine infusion in advanced non-small cell lung carcinoma: a randomized phase II study of two different schedules in combination with cisplatin. Cancer 98 (2003) 337-343
12. Gridelli C., Gallo C., Ceribelli A., Gebbia V., Gamucci T., Ciardiello F., et al. Factorial phase III randomised trial of rofecoxib and prolonged constant infusion of gemcitabine in advanced non-small-cell lung cancer: the GEmcitabine-COxib in NSCLC (GECO) study. Lancet Oncol. 8 (2007) 500-512
13. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J. Natl. Cancer Inst. 92 (2000) 205-216
14. Rustin G.J., Nelstrop A.E., Bentzen S.M., Piccart M.J., and Bertelsen K. Use of tumour markers in monitoring the course of ovarian cancer. Ann. Oncol. 10 Suppl 1 (1999) 21-27
15. Armstrong D.K. Relapsed ovarian cancer: challenges and management strategies for a chronic disease. Oncologist 7 Suppl 5 (2002) 20-28
16. Dunton C.J. Management of treatment-related toxicity in advanced ovarian cancer. Oncologist 7 Suppl 5 (2002) 11-19
17. Pfisterer J., Plante M., Vergote I., du Bois A., Hirte H., Lacave A.J., et al. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J. Clin. Oncol. 24 (2006) 4699-4707
18. du Bois A., Lück H.J., Pfisterer J., Schroeder W., Blohmer J.U., Kimmig R., et al. Second-line carboplatin and gemcitabine in platinum sensitive ovarian cancer-a dose-finding study by the Arbeitsgemeinschaft Gynakologische Onkologie (AGO) Ovarian Cancer Study Group. Ann. Oncol. 12 (2001) 1115-1120
19. Orlando M., Nadal J., and Chacon R. Gemcitabine (G) and carboplatin (C) in patients (Pts) with relapsed ovarian cancer (ROC): a Phase I-II study. Proc. Am. Soc. Clin. Oncol. 19 (2000) A1594
20. Tonato M., Mosconi A.M., and Martin C. Safety profile of gemcitabine. Anticancer Drugs 6 Suppl 6 (1995) 27-32
21. Green M.R. Gemcitabine safety overview. Semin. Oncol. 23 5 Suppl 10 (1996) 32-35
22. Abbruzzese J.L., Grunewald R., Weeks E.A., Gravel D., Adams T., Nowak B., et al. A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J. Clin. Oncol. 9 (1991) 491-498
23. Grunewald R., Abbruzzese J.L., Tarassoff P., and Plunkett W. Saturation of 2′,2′-difluorodeoxycytidine 5′-triphosphate accumulation by mononuclear cells during a phase I trial of gemcitabine. Cancer Chemother Pharmacol 27 (1991) 258-262
24. Grunewald R., Kantarjian H., Keating M.J., Abbruzzese J., Tarassoff P., and Plunkett W. Pharmacologically directed design of the dose rate and schedule of 2′,2′-difluorodeoxycytidine (Gemcitabine) administration in leukemia. Cancer Res. 50 (1990) 6823-6826
25. Bouffard D.Y., Laliberte J., and Momparler R.L. Kinetic studies on 2′,2′-difluorodeoxycytidine (gemcitabine) with purified human deoxycytidine kinase and cytidine deaminase. Biochem. Pharmacol. 45 (1993) 1857-1861
26. Gandhi V., Plunkett W., Du M., Ayres M., and Estey E.H. Prolonged infusion of gemcitabine: clinical and pharmacodynamic studies during a phase I trial in relapsed acute myelogenous leukemia. J. Clin. Oncol. 20 (2002) 665-673
27. Patel S.R., Gandhi V., Jenkins J., Papadopolous N., Burgess M.A., Plager C., et al. Phase II clinical investigation of gemcitabine in advanced soft tissue sarcomas and window evaluation of dose rate on gemcitabine triphosphate accumulation. J. Clin. Oncol. 19 (2001) 3483-3489
28. Poplin E., Levy D.E., Berlin J., Rothenberg M., Cella D., Mitchell E., et al. Phase III trial of gemcitabine (30-minute infusion) versus gemcitabine (fixed-dose-rate infusion [FDR]) versus gemcitabine + oxaliplatin(GEMOX) in patients with advanced pancreatic cancer (E6201) [abstract]. J. Clin. Oncol. 24 18S (2006) LBA4004
29. Louvet C., Labianca R., Hammel P., Lledo G., Zampino M.G., André T., et al. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J. Clin. Oncol. 23 (2005) 3509-3516
30. Pereira J.R., Fein L., Del Giglio A., Blajman C.R., Richardet E., Schwartsmann G., et al. Gemcitabine administered as a short infusion versus a fixed dose rate in combination with cisplatin for the treatment of patients with advanced non-small cell lung cancer. Lung Cancer 58 (2007) 80-87
31. Soh L.T., and Ho T.H. Gemcitabine plus carboplatin in patients with paclitaxel and platinum-resistant epithelial ovarian cancer [abstract]. Seventh Biennial Meeting of the International Gynecologic Cancer Society. Int. J. Gynecol. Cancer 9 Suppl 1 (1999) 15
32. Parmar M.K., Ledermann J.A., Colombo N., du Bois A., Delaloye J.F., Kristensen G.B., et al. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet 361 (2003) 2099-2106