A phase II trial and pharmacokinetic study of oxaliplatin in children with refractory solid tumors: A Children's Oncology Group study

Pediatric Blood and Cancer

Volumn 55, Issue 3, 2010, Pages 440-445

  Beaty III, Orren ^a   Berg, Stacey ^b   Blaney, Susan ^b   Malogolowkin, Marcio ^c   Krailo, Mark ^d   Knight, Ronald ^e   Schaiquevich, Paula ^f   Stewart, Clinton ^f   Chen, Zhengjia ^d   Nelson, Marvin ^c   Voss, Stephan ^g   Ivy, S Percy ^h   Adamson, Peter C ⁱ  

^a Mission Hospital   (United States)

^b TEXAS CHILDREN S CANCER CENTER   (United States)

^c CHILDREN S HOSPITAL LOS ANGELES   (United States)

^d CHILDREN S ONCOLOGY GROUP   (United States)

^e SANOFI   (France)

^f ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^g BOSTON CHILDREN S HOSPITAL   (United States)

^h NATIONAL CANCER INSTITUTE   (United States)

ⁱ CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

Author keywords

Oxaliplatin; Pediatric; Pharmacokinetics; Phase II study; Refractory solid tumor

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; OXALIPLATIN; ANTINEOPLASTIC AGENT; PLATINUM COMPLEX;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; AREA UNDER THE CURVE; ARM MOVEMENT; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BONE MARROW SUPPRESSION; BRAIN STEM; CANCER GRADING; CANCER PATIENT; CANCER RELAPSE; CATHETER INFECTION; CHILD; CHILDHOOD CANCER; CLINICAL TRIAL; DEATH; DEHYDRATION; DISTRIBUTION VOLUME; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG TOLERABILITY; DYSESTHESIA; DYSPNEA; EPENDYMOMA; EWING SARCOMA; FATIGUE; FEMALE; GLIOMA; GRANULOCYTE; HEMOGLOBIN BLOOD LEVEL; HEPATOBLASTOMA; HUMAN; HYPERCALCEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOXIA; ILEUS; JAW DISEASE; LEUKOCYTE COUNT; LIMB PAIN; LUNG INFECTION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MOTOR DYSFUNCTION; MULTIPLE CYCLE TREATMENT; MUSCLE CRAMP; NAUSEA; NEUROBLASTOMA; NEUROECTODERM TUMOR; NEUTROPHIL COUNT; OSTEOSARCOMA; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RHABDOMYOSARCOMA; SEIZURE; SENSORY DYSFUNCTION; SIDE EFFECT; SOLID TUMOR; THORAX PAIN; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT RESPONSE; UPPER GASTROINTESTINAL BLEEDING; URINARY TRACT INFECTION; VOMITING; ADOLESCENT; ADULT; INFANT; MULTICENTER STUDY; NEOPLASM; PRESCHOOL CHILD;

ADOLESCENT; ANTINEOPLASTIC AGENTS; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; INFANT; MALE; NEOPLASMS; ORGANOPLATINUM COMPOUNDS; YOUNG ADULT;

EID: 77955508388     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.22544     Document Type: Article

References (40)

1. Gibbons GR, Page JD, Mauldin SK, et al. Role of carrier ligand in platinum resistance in L1210 cells. Cancer Res 1990;50:6497-6501.
2. Mamenta EL, Poma EE, Kaufmann WK, et al. Enhanced replicative bypass of platinum-DNA adducts in cisplatin-resistant human ovarian carcinoma cell lines. Cancer Res 1994;54:3500-3505.
3. Page JD, Husain I, Sancar A, et al. Effect of the diaminocyclohexane carrier ligand on platinum adduct formation, repair, and lethality. Biochemistry 1990;29:1016-1024. (Pubitemid 20053817)
4. Raymond E, Faivre S, Woynarowski JM, et al. Oxaliplatin: Mechanism of action and antineoplastic activity. Semin Oncol 1998;25:4-12.
5. Woynarowski JM, Chapman WG, Napier C, et al. Sequence- and region-specificity of oxaliplatin adducts in naked and cellular DNA. Mol Pharmacol 1998;54:770-777.
6. Rixe O, Ortuzar W, Alvarez M, et al. Oxaliplatin, tetraplatin, cisplatin, and carboplatin: Spectrum of activity in drug-resistant cell lines and in the cell lines of the National Cancer Institute's Anticancer Drug Screen panel. Biochem Pharmacol 1996;52:1855-1865.
7. Scheeff ED, Briggs JM, Howell SB. Molecular modeling of the intrastrand guanine-guanine DNA adducts produced by cisplatin and oxaliplatin. Mol Pharmacol 1999;56:633-643.
8. Schmidt W, Chaney SG. Role of carrier ligand in platinum resistance of human carcinoma cell lines. Cancer Res 1993;53:799-805. (Pubitemid 23077865)
9. Dunn TA, Schmoll HJ, Grunwald V, et al. Comparative cytotoxicity of oxaliplatin and cisplatin in non-seminomatous germ cell cancer cell lines. Invest New Drugs 1997;15:109-114.
10. Riccardi A, Ferlini C, Meco D, et al. Antitumour activity of oxaliplatin in neuroblastoma cell lines. Eur J Cancer 1999;35:86-90.
11. Mathe G, Kidani Y, Noji M, et al. Antitumor activity of l-OHP in mice. Cancer Lett 1985;27:135-143.
12. Pendyala L, Creaven PJ. In vitro cytotoxicity, protein binding, red blood cell partitioning, and biotransformation of oxaliplatin. Cancer Res 1993;53:5970-5976.
13. Pendyala L, Creaven PJ, Perez R, et al. Intracellular glutathione and cytotoxicity of platinum complexes. Cancer Chemother Pharmacol 1995;36:271-278.
14. Tashiro T, Kawada Y, Sakurai Y, et al. Antitumor activity of a new platinum complex, oxalato (trans-l-1,2-diaminocyclohexane)platinum (II): New experimental data. Biomed Pharmacother 1989;43:251-260. (Pubitemid 19153976)
15. Becouarn Y, Rougier P. Clinical efficacy of oxaliplatin monotherapy: Phase II trials in advanced colorectal cancer. Semin Oncol 1998;25:23-31.
16. Diaz-Rubio E, Sastre J, Zaniboni A, et al. Oxaliplatin as single agent in previously untreated colorectal carcinoma patients: A phase II multicentric study. Ann Oncol 1998;9:105-108. (Pubitemid 28125772)
17. Levi F, Perpoint B, Garufi C, et al. Oxaliplatin activity against metastatic colorectal cancer. A phase II study of 5-day continuous venous infusion at circadian rhythm modulated rate. Eur J Cancer 1993;29A:1280-1284.
18. Machover D, Diaz-Rubio E, de Gramont A, et al. Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines. Ann Oncol 1996;7:95-98.
19. Giacchetti S, Perpoint B, Zidani R, et al. Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 2000;18:136-147.
20. Levi F, Misset JL, Brienza S, et al. A chronopharmacologic phase II clinical trial with 5-fluorouracil, folinic acid, and oxaliplatin using an ambulatory multichannel programmable pump. High antitumor effectiveness against metastatic colorectal cancer. Cancer 1992;69:893-900.
21. Levi F, Zidani R, Misset JL. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. International Organization for Cancer Chronotherapy. Lancet 1997;350:681-686. (Pubitemid 27371165)
22. Levi FA, Zidani R, Vannetzel JM, et al. Chronomodulated versus fixed-infusion-rate delivery of ambulatory chemotherapy with oxaliplatin, fluorouracil, and folinic acid (leucovorin) in patients with colorectal cancer metastases: A randomized multi-institutional trial. J Natl Cancer Inst 1994;86:1608-1617.
23. Spunt SL, Freeman BB III, Billups CA, et al. Phase I clinical trial of oxaliplatin in children and adolescents with refractory solid tumors. J Clin Oncol 2007;25:2274-2280. (Pubitemid 46954655)
24. Therasse P, Arbuck SG, Eisenhauer EA, 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 2000;92:205-216.
25. Bagley CM, Jr. Measurement of brain tumor volumes by the perimeter method. J Clin Oncol 2001;19:3159-3160.
26. Sorensen AG, Patel S, Harmath C, et al. Comparison of diameter and perimeter methods for tumor volume calculation. J Clin Oncol 2001;19:551-557.
27. Morrison JG, White P, McDougall S, et al. Validation of a highly sensitive ICP-MS method for the determination of platinum in biofluids: Application to clinical pharmacokinetic studies with oxaliplatin. J Pharm Biomed Anal 2000;24:1-10.
28. Bauer RJ, Guzy S. Monte Carlo parametric expectation maximization (MC-PEM) method for analyzing population pharmacokinetic/pharmacodynamic data. In: D'Argenio DZ, (Ed.), Advanced methods of pharmacokinetic and pharmacodynamic systems analysis, Vol. 3. Netherlands: Springer; 2004. pp 135-163.
29. D'Argenio DZ, Schumitzky A. Adapt II user's guide. Los Angeles: Biomedical Simulations Resource, University of Southern California: 1990.
30. Chang MN, O'Brien PC. Confidence intervals following group sequential tests. Control Clin Trials 1986;7:18-26.
31. Chang MN, Therneau TM, Wieand HS, et al. Designs for group sequential phase II clinical trials. Biometrics 1987;43:865-874.
32. Kaliszewski J, Marques MB, Saif MW. Immune-mediated thrombocytopenia resulting from sensitivity to Oxaliplatin. Am J Hematol 2006;81:193-198.
33. Becouarn Y, Ychou M, Ducreux M, et al. Phase II trial of oxaliplatin as first-line chemotherapy in metastatic colorectal cancer patients. Digestive Group of French Federation of Cancer Centers. J Clin Oncol 1998;16:2739-2744.
34. Rothenberg ML, Oza AM, Bigelow RH. Superiority of oxaliplatin and fluorouracil-leucovorin compared with either therapy alone in patients with progressive colorectal cancer after irinotecan and fluorouracil-leucovorin interim results of a phase III trial. J Clin Oncol 2003;21:2059-2069.
35. Pasetto LM, D'Andrea MR, Rossi E, et al. Oxaliplatin-related neurotoxicity: How and why? Crit Rev Oncol/Hematolgy 2006;59:159-168.
36. Wilson RH, Lehky T, Thomas RR. Acute oxaliplatin-induced peripheral nerve hyperexcitability. J Clin Oncol 2002;20:1767-1774. (Pubitemid 34273265)
37. Graham MA, Lockwood GF, Greenslade D, et al. Clinical pharmacokinetics of oxaliplatin: A critical review. Clin Cancer Res 2000;6:1205-1218.
38. Bastian G, Barrail A, Urien S. Population pharmacokinetics of oxaliplatin in patients with metastatic cancer. Anticancer Drugs 2003;14:817-824. (Pubitemid 38339786)
39. Delord JP, Umlil A, Guimbaud R, et al. Population pharmacokinetics of oxaliplatin. Cancer Chemother Pharmacol 2003;51:127-131.
40. Fouladi M, Blaney SM, Poussaint TY, et al. Phase II study of oxaliplatin in children with recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal tumors, and atypical teratoid rhabdoid tumors: A pediatric brain tumor consortium study. Cancer 2006;107:2291-2297.