A phase II study of intravenous exatecan administered daily for 5 days, every 3 weeks to patients with biliary tract cancers Journal Article
| Authors: | Abou-Alfa, G. K.; Rowinsky, E. K.; Patt, Y. Z.; Schwartz, G. K.; Kelsen, D. P.; Sharma, S.; Siegel, E.; Becerra, C. R.; Eckhardt, S. G.; Feit, K.; De Jager, R.; O'Reilly, E. M. |
| Article Title: | A phase II study of intravenous exatecan administered daily for 5 days, every 3 weeks to patients with biliary tract cancers |
| Abstract: | Purpose: Exatecan is a hexacyclic topoisomerase-1 inhibitor that has broad in vitro and in vivo activity. A multicenter phase II study to determine the antitumor activity of exatecan was conducted in patients with advanced cholangiocarcinoma and gallbladder carcinoma. Methods: Patients with 0 to 1 prior chemotherapy regimens, adequate major organ function, and metastatic disease were eligible. Exatecan was administered at a dose of 0.5 mg/m 2 IV over 30 minutes daily on days 1 through 5 every 21 days. The primary end point was overall response rate: complete response and partial response (PR). A Simon optimal 2-stage design was employed. Response was assessed every 6 weeks. Results: Forty-two patients were enrolled. Two of 41 evaluated patients (4.9%) had a PR, 4 patients (9.8%) had a minor response, and 12 had stable disease. Twenty patients (51.2%) had progressive disease. The major toxicity was grade 3/4 neutropenia. The median overall survival was 7 months. The 6-month survival rate was 56.1% and the 12-month survival rate was 31.7%. Conclusion: Exatecan has minimal activity in advanced biliary tree cancers. Toxicity was predictable and manageable. Copyright © 2005 by Lippincott Williams & Wilkins. |
| Keywords: | adult; cancer survival; clinical article; treatment outcome; aged; aged, 80 and over; middle aged; survival rate; clinical trial; fatigue; neutropenia; fluorouracil; liver function; capecitabine; gemcitabine; adenocarcinoma; phase 2 clinical trial; anemia; bone marrow suppression; nausea; thrombocytopenia; vomiting; drug administration schedule; camptothecin; antineoplastic activity; abdominal pain; fever; alanine aminotransferase; aspartate aminotransferase; bilirubin; drug distribution; multicenter study; folinic acid; thrombocyte count; drug clearance; area under curve; bile duct carcinoma; bile duct neoplasms; bile ducts, intrahepatic; cholangiocarcinoma; drug blood level; high performance liquid chromatography; drug half life; gallbladder carcinoma; gallbladder neoplasms; phase ii; gallbladder cancer; exatecan; biliary tract cancer; biliary tract cancers; half-life; dna topoisomerases, type i; dx-8951f; topoisomerase-1 inhibitor |
| Journal Title: | American Journal of Clinical Oncology |
| Volume: | 28 |
| Issue: | 4 |
| ISSN: | 0277-3732 |
| Publisher: | Lippincott Williams & Wilkins |
| Date Published: | 2005-08-01 |
| Start Page: | 334 |
| End Page: | 339 |
| Language: | English |
| DOI: | 10.1097/01.coc.0000158829.63542.2c |
| PUBMED: | 16062073 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 7" - "Export Date: 24 October 2012" - "CODEN: AJCOD" - "Source: Scopus" |
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