Abstract | BACKGROUND: METHODS: A single academic center performed this phase II trial. Eligible patients had unresectable or metastatic soft-tissue sarcomas, Eastern Cooperative Group performance status of 0-2, adequate organ function, and <or=1 prior regimen. Gemcitabine 800 mg/m2 was given over 90 minutes on Days 1 and 8 of a 21-day cycle after administration of vinorelbine 25 mg/m2. Dosing schedule was modified for toxicity (doses constant but administered on Days 1 and 15 of a 28-day cycle). Dose reductions were allowed if unacceptable toxicities recurred. RESULTS: The study accrued 40 patients, and 248 dosing cycles were administered (range, 1-32). No treatment-related deaths occurred. Of 9 episodes of grade 4 toxicities, 8 were hematologic. Of 38 episodes of grade 3 toxicity, 24 were hematologic. Clinical benefit was seen in 25% of patients and was defined as complete response (CR), partial response (PR), or stable disease (SD) at >4 months. There has been 1 CR lasting >1 year in a patient with high-grade pleomorphic spindle-cell sarcoma. CONCLUSIONS:
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Authors | Palma Dileo, Jeffrey A Morgan, David Zahrieh, Jayesh Desai, Jeanine M Salesi, David C Harmon, M Travis Quigley, Kathleen Polson, George D Demetri, Suzanne George |
Journal | Cancer
(Cancer)
Vol. 109
Issue 9
Pg. 1863-9
(May 01 2007)
ISSN: 0008-543X [Print] United States |
PMID | 17385194
(Publication Type: Clinical Trial, Phase II, Historical Article, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright (c) 2007 American Cancer Society |
Chemical References |
- Deoxycytidine
- Vinblastine
- Vinorelbine
- Gemcitabine
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Topics |
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Deoxycytidine
(administration & dosage, adverse effects, analogs & derivatives)
- Disease-Free Survival
- Dose-Response Relationship, Drug
- Female
- History, 16th Century
- History, 17th Century
- Humans
- Male
- Sarcoma
(drug therapy, mortality)
- Soft Tissue Neoplasms
(drug therapy, mortality)
- Treatment Outcome
- Vinblastine
(administration & dosage, adverse effects, analogs & derivatives)
- Vinorelbine
- Gemcitabine
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