Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma Journal Article
| Authors: | Galsky, M. D.; Mironov, S.; Iasonos, A.; Scattergood, J.; Boyle, M. G.; Bajorin, D. F. |
| Article Title: | Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma |
| Abstract: | Purpose: The purpose of this single-center phase II study was to determine the activity of pemetrexed administered as second-line therapy in patients with advanced urothelial carcinoma. Methods: Patients with advanced urothelial carcinoma that had relapsed after receiving perioperative chemotherapy, or progressed on first-line chemotherapy for metastatic disease, were eligible for enrollment. Patients received pemetrexed 500 mg/m2 every 21 days along with folic acid and vitamin B12 supplementation. Results: A total of 13 patients were enrolled. An objective response was achieved in 1/12 evaluable patients for an overall response rate of 8% (90% upper limit 29%). This level of activity did not meet criteria for expansion based on the pre-defined optimal 2-stage Simon design and the trial was concluded. Treatment was generally well tolerated, however, 2/13 patients developed febrile neutropenia. Non-hematologic grade ≥ 3 toxicity was rare. Conclusions: Pemetrexed as second-line therapy in advanced urothelial carcinoma is associated with modest activity. The role of this novel antifolate in chemotherapy-naïve patients warrants further investigation. © 2006 Springer Science+Business Media, LLC. |
| Keywords: | adult; clinical article; controlled study; treatment outcome; aged; clinical trial; constipation; drug tolerability; fatigue; neutropenia; salvage therapy; cisplatin; diarrhea; drug withdrawal; side effect; gemcitabine; paclitaxel; cancer patient; chemotherapy; anorexia; carboplatin; metastasis; controlled clinical trial; multiple cycle treatment; phase 2 clinical trial; anemia; antimetabolites, antineoplastic; mucosa inflammation; nausea; thrombocytopenia; drug administration schedule; dexamethasone; urinary bladder neoplasms; ifosfamide; drug dose escalation; dyspnea; febrile neutropenia; rash; chemotherapy induced emesis; hypokalemia; hyponatremia; urothelium; guanine; pelvic neoplasms; urothelial carcinoma; patient compliance; vitamin supplementation; cancer relapse; urogenital tract tumor; folic acid; carcinoma, transitional cell; bladder carcinoma; folic acid antagonist; kidney pelvis carcinoma; administration, oral; glutamates; infusions, intravenous; pemetrexed; bilirubin blood level; allergic reaction; vitamin b complex; metastatic; hypocalcemia; cyanocobalamin; vitamin b 12; urethra carcinoma; musculoskeletal pain; urethral neoplasms |
| Journal Title: | Investigational New Drugs |
| Volume: | 25 |
| Issue: | 3 |
| ISSN: | 0167-6997 |
| Publisher: | Springer |
| Date Published: | 2007-06-01 |
| Start Page: | 265 |
| End Page: | 270 |
| Language: | English |
| DOI: | 10.1007/s10637-006-9020-9 |
| PUBMED: | 17146733 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 38" - "Export Date: 17 November 2011" - "CODEN: INNDD" - "Source: Scopus" |
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