A randomised, double-blind, phase II study of two doses of pemetrexed in the treatment of platinum-resistant, epithelial ovarian or primary peritoneal cancer

European Journal of Cancer

Volumn 45, Issue 8, 2009, Pages 1415-1423

  Vergote, Ignace ^a   Calvert, Hilary ^b   Kania, Marek ^c   Kaiser, Christopher ^c   Zimmermann, Annamaria Hayden ^c   Sehouli, Jalid ^d  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b NEWCASTLE UNIVERSITY   (United Kingdom)

^c ELI LILLY AND COMPANY   (United States)

^d CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

ERCC1; Ovarian cancer; Pemetrexed; RFC

Indexed keywords

CARBOPLATIN; CISPLATIN; DEXAMETHASONE; EXCISION REPAIR CROSS COMPLEMENTING PROTEIN 1; MESSENGER RNA; PEMETREXED; PLATINUM DERIVATIVE; REDUCED FOLATE CARRIER; REDUCED FOLATE CARRIER 1 PROTEIN; TUMOR MARKER; UNCLASSIFIED DRUG;

ADULT; AGED; ANEMIA; ARTICLE; ASCITES; ASTHENIA; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GENE EXPRESSION; HUMAN; HUMAN TISSUE; ILEUS; LETHARGY; LEUKOPENIA; MAJOR CLINICAL STUDY; MALAISE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MULTIPLE DRUG DOSE; NAUSEA; NAUSEA AND VOMITING; NEUTROPENIA; OUTCOME ASSESSMENT; OVARY CANCER; PERITONEUM CANCER; PHASE 2 CLINICAL TRIAL; PRIMARY TUMOR; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; RASH; SEPSIS; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; CHI-SQUARE DISTRIBUTION; DISEASE-FREE SURVIVAL; DNA-BINDING PROTEINS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, NEOPLASM; ENDONUCLEASES; FEMALE; FOLIC ACID ANTAGONISTS; GENE EXPRESSION; GLUTAMATES; GUANINE; HUMANS; KAPLAN-MEIERS ESTIMATE; MEMBRANE TRANSPORT PROTEINS; MIDDLE AGED; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; PLATINUM COMPOUNDS; PROGNOSIS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 65249113396     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2008.12.013     Document Type: Article

References (39)

1. Jemal A., Siegel R., Ward E., Murray T., Xu J., and Thun M.J. Cancer statistics, 2007. CA Cancer J Clin 57 (2007) 43-66
2. Markman M., and Hoskins W. Responses to salvage chemotherapy in ovarian cancer: a critical need for precise definitions of the treated population. J Clin Oncol 10 (1992) 513-514
3. Vogelzang N.J., Rusthoven J.J., Symanowski J., et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21 (2003) 2636-2644
4. Hanna N., Shepherd F.A., Fossella F.V., et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22 (2004) 1589-1597
5. Kano Y., Akutsu M., Tsunoda S., et al. Schedule-dependent interactions between pemetrexed and cisplatin in human carcinoma cell lines in vitro. Oncol Res 16 (2006) 85-95
6. Tomassetti A., Mangiarotti F., Mazzi M., et al. The variant hepatocyte nuclear factor 1 activates the P1 promoter of the human alpha-folate receptor gene in ovarian carcinoma. Cancer Res 63 (2003) 696-704
7. Takimoto C.H., Hammond-Thelin L.A., Latz J.E., et al. Phase I and pharmacokinetic study of pemetrexed with high-dose folic acid supplementation or multivitamin supplementation in patients with locally advanced or metastatic cancer. Clin Cancer Res 13 (2007) 2675-2683
8. 12 in Japanese patients with solids. Brit J Cancer 95 (2006) 677-682
9. Miotti S., Bagnoli M., Ottone F., Tomasseti A., Colnaghi M.I., and Canevari S. Simultaneous activity of two different mechanisms of folate transport in ovarian carcinoma cell lines. J Cell Biochem 65 (1997) 479-491
10. Corona G., Giannini F., Fabris M., Toffoli G., and Boiocchi M. Role of folate receptor and reduced folate carrier in the transport of 5-methyltetrahydrofolic acid in human ovarian carcinoma cells. Int J Cancer 75 (1998) 125-133
11. Wang Y., Zhao R., and Goldman I.D. Characterization of a folate transporter in HeLa cells with a low pH optimum and high affinity for pemetrexed distinct from the reduced folate carrier. Clin Cancer Res 10 (2004) 6256-6264
12. Tomassetti A., Mangiarotti F., Mazzi M., et al. The variant hepatocyte nuclear factor 1 activates the P1 promoter of the human alpha-folate receptor gene in ovarian carcinoma. Cancer Res 63 (2003) 696-704
13. Therasse P., Arbuck S.G., Eisenhauer E.A., 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. National Cancer Institute. Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events, v3.0 (CTCAE), 3/03 update. http://ctep.cancer.gov/reporting/ctc.html.
15. Vergote I., Rustin G.J., Eisenhauer E.A., et al. Re: new guidelines to evaluate the response to treatment in solid tumors [ovarian cancer]. Gynecologic cancer intergroup. J Natl Cancer Inst 92 (2000) 1534-1535
16. Rustin G.J., Quinn M., Thigpen T., et al. Re: new guidelines to evaluate the response to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst 96 (2004) 487-488
17. Mendelsohn L.G., Shih C., Chen V., Habeck L.L., Gates S.B., and Shackelford K.A. Enzyme inhibition, polyglutamylation, and the effect of LY231514 (MTA) on purine biosynthesis. Semin Oncol 26 (1999) 42-47
18. Schneider E., and Ryan T.J. Gamma-glutamyl hydrolase and drug resistance. Clin Chim Acta 374 1-2 (2006) 25-32
19. Salonga D., Danenberg K.D., Johnson M., et al. Colorectal tumors responding to 5-fluorouracil have low gene expression levels of dihydropyrimidine dehydrogenase, thymidylate synthase, and thymidine phosphorylase. Clin Cancer Res 6 (2000) 1322-1327
20. Lord R.V., Brabender J., Gandara D., et al. Low ERCC1 expression correlates with prolonged survival after cisplatin plus gemcitabine chemotherapy in non-small cell lung cancer. Clin Cancer Res 8 (2002) 2286-2291
21. Rouzier R., Rajan R., Wagner P., et al. Microtubule-associated protein tau: a marker of paclitaxel sensitivity in breast cancer. Proc Natl Acad Sci USA 102 (2005) 8315-8320
22. Mayr D., Pannekamp U., Baretton G.B., et al. Immunohistochemical analysis of drug resistance-associated proteins in ovarian carcinomas. Pathol Res Pract 196 (2000) 469-475
23. In: Crowley J., and Ankerst D.P. (Eds). Handbook of statistics in clinical oncology. 2nd ed. (2006), Chapman & Hall - CRC, New York
24. Kaplan E.L., and Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958) 457-481
25. Miller R., and Siegmund D. Maximally selected chi square statistics. Biometrics 38 (1982) 1011-1016
26. Llombart-Cussac A., Martin M., Harbeck N., et al. A randomized, double-blind, phase II study of two doses of pemetrexed as first-line chemotherapy for advanced breast cancer. Clin Cancer Res 13 (2007) 3652-3659
27. Cullen M.H., Zatloukal P., Sörenson S., et al. A randomized phase III trial comparing standard and high-dose pemetrexed as second-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer. Ann Oncol 19 (2008) 939-945
28. Nieboer P., de Vries E.G., Mulder N.H., and van der Graff W.T. Relevance of high-dose chemotherapy in solid tumors. Cancer Treat Rev 31 (2005) 210-225
29. Mutch D.G., Orlando M., Goss T., et al. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol 25 (2007) 2811-2818
30. Bhoola S., and Hoskins W.J. Diagnosis and management of epithelial ovarian cancer. Obstet Gynecol 107 (2006) 1399-1410
31. Horowitz N.S., Penson R.T., Campos S.M., et al. Combination carboplatin and pemetrexed for the treatment of platinum sensitive recurrent ovarian cancer. J Clin Oncol 26 Suppl. (2008) 298 [abstr 5523]
32. Sehouli J., Kania M., Zimmerman A., Look K., and Mustea A. A phase I/II study of pemetrexed in combination with carboplatin in patients with platin sensitive recurrent ovarian or peritoneal cancer (PSOC). J Clin Oncol 26 Suppl. (2008) 685 [abstr 16513]
33. Gossage L., and Madhusudan S. Current status of excision repair cross complementing-group 1 (ERCC1) in cancer. Cancer Treat Rev 33 (2007) 565-577
34. Dabholkar M., Bostick-Bruton F., Weber C., and Reed E. ERCC1 and ERCC2 expression in malignant tissues from ovarian cancer patients. J Natl Cancer Inst 84 (1992) 1512-1517
35. Smith S., Su D., Rigault de la Longrais I.A., et al. ERCC1 genotype and phenotype in epithelial ovarian cancer identify patients likely to benefit from paclitaxel treatment in addition to platinum-based therapy. J Clin Oncol 25 (2007) 5172-5179
36. Matherly L., Hou Z., and Deng Y. Human reduced folate carrier: translation of basic biology to cancer etiology and therapy. Cancer Metast Rev 26 (2007) 111-128
37. Chattopadhyay S., Zhao R., Krupenko S.A., and Goldman I.D. The inverse relationship between reduced folate carrier function and pemetrexed activity in a human colon cancer cell line. Mol Cancer Ther 5 (2006) 438-449
38. Qiu A., Jansen M., Sakaris A., Min S.H., et al. Identification of an intestinal folate transporter and the molecular basis for hereditary folate malabsorption. Cell 127 (2006) 917-928
39. Marsh S., Paul J., King C.R., Gifford G., McLeod H.L., and Brown R. Pharmacogenetic assessment of toxicity and outcome after platinum plus taxane chemotherapy in ovarian cancer: the Scottish randomised trial in ovarian cancer. J Clin Oncol 25 (2007) 4528-4535