Phase II study of Triapine® in patients with metastatic renal cell carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC IND.161)

Investigational New Drugs - Tập 25 Số 5 - Trang 471-477 - 2007
Jennifer J. Knox1, Sébastien J. Hotte2, Christian Kollmannsberger3, Eric Winquist4, B. Fisher5, Elizabeth Eisenhauer5
1Department of Medical Oncology, University Health Network-OCI/Princess Margaret Hospital, Toronto, Canada
2Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Canada
3British Columbia Cancer Agency- Vancouver Cancer Centre, Vancouver, Canada
4London Health Sciences Centre, London, Canada
5NCIC Clinical Trials Group, Queen's University, Kingston, CANADA

Tóm tắt

Từ khóa


Tài liệu tham khảo

Cory JG, Chiba P (1989) Combination chemotherapy directed at the components of nucleoside diphosphate reductase (Chapter 13). In: Cory JG, Cory AM (eds) International encyclopedia of pharmacology and therapeutics—inhibitors of ribonucleotide diphosphate reductase activity. Pergamon, NY, Section 128, pp 245–264

Wright JA, Chan AK, Choy BK et al (1990) Regulation and drug resistance mechanisms of mammalian ribonucleotide reductase, and the significance to DNA synthesis. Biochem Cell Biol 68:1364–1371

Cory JG (1989) Role of ribonucleotide reductase in cell division (Chapter 1). In: Cory JG, Cory AM (eds) International encyclopedia of pharmacology and therapeutics – inhibitors of ribonucleotide diphosphate reductase activity. Pergamon, NY, Section 128, pp 1–16

Elford HL, Freese M, Passamani E, Morris HP (1970) Ribonucleotide reductase and cell proliferation. Variations of ribonucleotide reductase activity with tumor growth rate in a series of rat hepatomas. J Biol Chem 245:5228–5233

Cory JG, Cory AH, Rappa G et al (1994) Inhibitors of ribonucleotide reductase. Comparative effects of amino- and hydroxy-substituted pyridine-2-carboxaldehyde thiosemicarbazones. Biochem Pharmacol 48;335–344

Liu MC, Lin TS, Sartorelli AC (1992) Synthesis and antitumor activity of amino derivatives of pyridine-2-carboxaldehyde thiosemicarbazone. J Med Chem 35:3672–3677

Liu MC, Lin TS, Penketh P, Sartorelli AC (1995) Synthesis and antitumor activity of 4- and 5-substituted derivatives of isoquinoline-1-carboxaldehyde thiosemicarbazone. J Med Chem 38:4234–4243

Finch RA, Liu M, Grill SP et al (2000) Triapine (3-aminopyridine-2-carboxaldehyde- thiosemicarbazone): a potent inhibitor of ribonucleotide reductase activity with broad spectrum antitumor activity. Biochem Pharmacol 59:983–991

Investigator’s Brochure for Triapine® 4 March 2003

Feun L, Modiano M, Lee K, Mao J, Marini A, Savaraj N, Plezia P, Almassian B, Colacino E, Fischer J, MacDonald S (2002) Phase I and pharmacokinetic study of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) using a single intravenous dose schedule. Cancer Chemother Pharmacol 50(3):223–229

Murren J, Modiano M, Clairmont C, Lambert P, Savaraj N, Doyle T, Sznol M (2003). Phase I and pharmacokinetic study of triapine, a potent ribonucleotide reductase inhibitor, administered daily for five days in patients with advanced solid tumors. Clin Cancer Res 9(11):4092–4100

Giles FJ, Fracsso PM, Kantarjian HM, Cortes JE, Brown RA, Verstovsek S, Alvarado Y, Thomas DA, Faderl S, Garci-Manero G, Wright LP, Samson T, Cahill A, Lambert P, Plunkett W, Sznol M, DiPersio JF, Gandhi V (2003) Phase I and pharmacodynamic study of triapine, a novel ribonecleotide reductase inhibitor, in patients with advanced leukemia. Leuk Res 27(12):1077–1083

Wadler S, Makower D, Clairmont C, Lambert P, Fehn K, Sznol M (2004) Phase I and pharmacokinetic study of the ribonucleotide reductase inhibitor, 3-aminopyridine-2-carboxaldehyde thiosemicarbazone, administered by 96-hour intravenous continuous infusion. J Clin Oncol 22(9):1553–1563

Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ (2004) American Cancer Society: Cancer statistics. CA Cancer J Clin 54(1):8–29

Motzer RJ, Russo P, Nanus DM, Berg WJ (1997) Renal cell carcinoma. Curr Probl Cancer 21:185–232

Coppin C, Porzsolt F, Autenrieth M et al (2007) Immunotherapy for Advanced Renal Cell Carcinoma-Cochrane Database of Systematic Reviews: The Cochrane Library 1

Escudier B, Szczylik C, Eisen T, Stadler WM, Schwartz B, Shan M, Bukowski RM (2005). Randomized Phase III trial of the Raf kinase and VEGFR inhibitor sorafenib (BAY 43-9006) in patients with advanced renal cell carcinoma (RCC). Proc Am Soc Clin Oncol 23:380 (abstr 4510)

Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Kim ST, Baum CM, Figlin RA (2006) Phase III randomized trial of sunitinib malate (SU11248) versus interferon-alfa (IFN-α) as first-line systemic therapy for patients with metastatic renal cell carcinoma (mRCC). Proc Am Soc Clin Oncol 24 (abstr LBA3)

Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, O’Toole T, Park Y, Moore L (2006) A phase 3, randomized, 3-arm study of temsirolimus (TEMSR) or interferon-alpha (IFN) or the combination of TEMSR + IFN in the treatment of first-line, poor-risk patients with advanced renal cell carcinoma (adv RCC). Proc Am Soc Clin Oncol 24 (abstr LBA4)

Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, Van Oostrom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors (RECIST guidelines). J Natl Cancer Inst 92:205–216

Zee B, Melnychuck D, Dancey J, Eisenhauer E (1999) Multinomial phase II cancer trials incorporating response and early progression. J Biopharm Stat 9(2):351–363

Dent S, Zee B, Dancey J, Hanauske A, Wanders J, Eisenhauer E (2001) Application of a new multivariate phase II stopping rule using response and early-progression. J Clin Oncol 19:785–791

Freidlin B, Dancey J, Korn E, Zee B, Eisenhauer E (2002) Multinomial phase II trial designs. J Clin Oncol 20(2):599

Foltz L, Bakul D, Wadsworth L, Broady R, Chi k, Eisenhauer, E, Kobayashi K, Kollmannsburger C (2006) Recognition and management of methemoglobinemia and hemolysis in a G6PD- deficient patient on experimental anticancer drug triapine. Am J Hematol 81:210–211

Groteluschen DL, Mahoney MR, Pitot, HC et al (2006) A multicenter phase 2 consortium (P2C) study of triapine in patients (pts) with advanced adenocarcinoma of the pancreas. Proc Am Soc Clin Oncol 24 (abstr 14118)

Atieh DM, Modiano M, Shriberg L et al (2004) A phase II trial of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP) in patients with metastatic breast cancer. Proc Am Soc Clin Oncol 24 (abstr 864)

Greeno E, Kindler HL, Peeters M et al (2006) A phase II study of triapine in combination with gemcitabine (G) in patients (pts) with unresectable or metastatic pancreatic cancer (PC). Proc Am Soc Clin Oncol 24 (abstr 4123)

MacKenzie MJ, Hirte HW, Moore MJ et al (2006) A phase II study of triapine in combination with gemcitabine in advanced pancreatic carcinoma. Proc Am Soc Clin Oncol; GI Can Symposium (abstr 147)

Traynor AM, Levy DE, Bayer GK et al (2006) ECOG 1503: A phase II trial of triapine (NSC#663249) with gemcitabine (T/G) as 2nd line treatment of non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 24 (abstr 17151)