Abstract | BACKGROUND: METHODS: Fit, consenting adult patients had advanced, metastatic, or locoregionally recurrent salivary gland cancer (any histologic subtype) that was not suitable for radiation or surgery. Therapy was comprised of gemcitabine at a dose of 1000 mg/m(2) administered intravenously on Days 1 and 8, and cisplatin at a dose of 70 mg/m(2) on Day 2, of a 21-day cycle. If carboplatin was substituted, it was administered on Day 1, targeted to an area under the concentration-time curve of 5 mg/mL/s. Response was assessed every 2 cycles according to Response Evaluation Criteria In Solid Tumors. Patients received up to 6 cycles. The primary endpoint was objective response. A 2-stage design was used, with a response rate of 45% required to declare the regimen active. RESULTS: Thirty-three eligible patients were enrolled, of whom 30 were response evaluable. Eight objective responses were observed (1 complete and 7 partial) for a response rate of 24% (95% confidence interval, 11-42%), with responses observed in all histologic subtypes. Toxicity was within that expected for this combination. CONCLUSIONS: This regimen did not meet the predefined criteria to be declared active in advanced salivary gland cancers. Enrollment of patients with these rare cancers into well-designed clinical trials remains an urgent priority.
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Authors | Scott A Laurie, Lillian L Siu, Eric Winquist, Andrew Maksymiuk, Erica L Harnett, Wendy Walsh, Dongsheng Tu, Wendy R Parulekar |
Journal | Cancer
(Cancer)
Vol. 116
Issue 2
Pg. 362-8
(Jan 15 2010)
ISSN: 0008-543X [Print] United States |
PMID | 19924794
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Deoxycytidine
- Carboplatin
- Gemcitabine
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Carboplatin
(administration & dosage)
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Disease-Free Survival
- Female
- Humans
- Male
- Middle Aged
- Survival Rate
- Time Factors
- Gemcitabine
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