The safety and tolerability of intravenous ASA404 when administered in combination with docetaxel (60 or 75 mg/m2) in Japanese patients with advanced or recurrent solid tumors

Japanese Journal of Clinical Oncology

Volumn 41, Issue 9, 2011, Pages 1067-1073

  Daga, Haruko ^a   Hida, Toyoaki ^b   Ishikawa, Shizu ^b   Shimizu, Junichi ^b   Tokunaga, Shinya ^a   Horio, Yoshitsugu ^b   Kobayashi, Ken ^c   Takeda, Koji ^a  

^a OSAKA CITY GENERAL HOSPITAL   (Japan)

^b AICHI CANCER CENTER HOSPITAL   (Japan)

^c NOVARTIS PHARMA K K   (Japan)

Author keywords

ASA404; Japanese; Pharmacokinetic; Safety; Vadimezan

Indexed keywords

DOCETAXEL; VADIMEZAN;

ADENOCARCINOMA; ADULT; ADVANCED CANCER; ALOPECIA; APPETITE; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RECURRENCE; CLINICAL ARTICLE; CONSTIPATION; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; ESOPHAGUS CARCINOMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLUSHING; HUMAN; HYPERURICEMIA; INJECTION SITE PAIN; LARGE CELL CARCINOMA; LEUKOPENIA; LUNG CARCINOMA; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; SIDE EFFECT; SOLID TUMOR; SQUAMOUS CELL CARCINOMA; STOMATITIS; THYMUS CANCER; TREATMENT RESPONSE; URINE RETENTION;

AGED; ALOPECIA; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; APPETITE; ASIAN CONTINENTAL ANCESTRY GROUP; CONSTIPATION; DRUG ADMINISTRATION SCHEDULE; FATIGUE; FEMALE; FEVER; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; NEOPLASMS; NEUTROPENIA; SEVERITY OF ILLNESS INDEX; TAXOIDS; TREATMENT OUTCOME; XANTHONES;

EID: 80052483302     PISSN: 03682811     EISSN: 14653621     Source Type: Journal    
DOI: 10.1093/jjco/hyr110     Document Type: Article

References (15)

1. Kelland LR. Targeting established tumour vasculature: a novel approach to cancer treatment. Curr Cancer Ther Rev 2005;1:1-9.
2. Siemann DW, Mercer E, Lepler S, Rojiani AM. Vascular targeting agents enhance chemotherapeutic agent activities in solid tumor therapy. Int J Cancer 2002;99:1-6.
3. Siim BG, Lee AE, Shalal-Zwain S, Pruijn FB, McKeage MJ, Wilson WR. Marked potentiation of the antitumour activity of chemotherapeutic drugs by the antivascular agent 5,6-dimethylxanthenone-4-acetic acid (DMXAA). Cancer Chemother Pharmacol 2003;51:43-52.
4. Pili R, Rosenthal MA, Mainwaring PN, Van Hazel G, Srinivas S, Dreicer R, et al. Phase II study of the addition of ASA404 (vadimezan, 5,6-dimethylxanthenone-4-acetic acid/DMXAA) to docetaxel in castration-refractory metastatic prostate cancer. Clin Cancer Res 2010;16:2906-14.
5. 2 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer. Lung Cancer 2009;65:192-7.
6. McKeage MJ, von Pawel J, Reck M, Jameson M, Rosenthal M, Sullivan R, et al. Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer. Br J Cancer 2008;99:2006-12.
7. Hida T, Tamiya M, Nishio M, Yamamoto N, Hirashima T, Horai T, et al. Phase I study of intravenous ASA404 (vadimezan) administered in combination with paclitaxel and carboplatin in Japanese patients with non-small cell lung cancer. Cancer Sci 2011;102:845-51.
8. Fossella F, DeVore R, Kerr R, Crawford J, Natale R, Dunphy F, et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small cell lung cancer previously treated with platinum containing chemotherapy regimens; the TAX320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 2000;18:2354-62.
9. Shepherd F, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000;18:2095-103.
10. ATTRACT-2 (NCT00738387). A Phase III, randomized, double-blind, placebo-controlled multi-center study of ASA404 in combination with docetaxel in second-line treatment of patients with locally advanced or metastatic (Stage IIIb/IV) non-small cell lung cancer (NSCLC). http://clinicaltrials.gov/ct2/show/NCT00738387?term=ASA404+NSCLC&rank=2
11. Iwao-Koizumi K, Matoba R, Ueno N, Jin Kim S, Ando A, Miyoshi Y, et al. Prediction of docetaxel response in human breast cancer by gene expression profiling. J Clin Oncol 2010;23:422-31.
12. Naito S, Tsukamoto T, Koga H, Harabayashi T, Sumiyoshi Y, Hoshi S, et al. Docetaxel plus prednisolone for the treatment of metastatic hormone-refractory prostate cancer: a multicenter phase II trial in Japan. Jpn J Clin Oncol 2008;38:365-72.
13. Takeda K, Negoro S, Tamura T, Nishiwaki Y, Kudoh S, Yokota S, et al. Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment of non-small cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104). Ann Oncol 2009;20: 835-41.
14. Eisenhauer E, Vermorken J. The taxoids: comparative clinical pharmacology and therapeutic potential. Drugs 1998;55:5-30.
15. ATTRACT-2. http://www.attractstudy.com/attract-2-researching-ASA404-in-cancer-treatment.jsp.