Phase II trial of gemcitabine as prolonged infusion in metastatic breast cancer

Schmid, Peter; Akrivakis, K.; Flath, Bernd; Grosse, Yvonne; Sezer, Orhan; Mergenthaler, H.; Possinger, K.

doi:10.1097/00001813-199908000-00001

Cited by 82 publications

(19 citation statements)

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“…This enzyme is saturated at plasma concentrations achieved after infusion for 30 min; therefore, accumulation of higher concentrations of intracellular dFdCTP cannot be achieved by higher dosage but only by prolonged infusion time. A phase I trial of continuous infusion of gemcitabine for up to 6 h has been reported in metastatic breast cancer patients [9], and a follow-up phase II trial showed an overall response rate of 25% and stable disease rate of 30% with that approach [10]. Continuous infusion of gemcitabine at the rate of 10 mg/m 2 /min was also used in a phase II trial in metastatic lung cancer [11].…”

Section: Introductionmentioning

confidence: 99%

Phase I Study of Prolonged-Infusion Gemcitabine Combined with Cyclophosphamide in Patients with Metastatic Carcinoma of the Breast: Tolerability of an Optimal Dose Schedule

et al. 2009

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Background: A phase I study was initiated to determine the maximum tolerated dose (MTD) of prolonged-infusion gemcitabine combined with cyclophosphamide in patients with metastatic breast carcinoma (MBC). Methods: Patients with MBC were treated with gemcitabine infusion at 10 mg/m²/min and cyclophosphamide by intravenous piggyback injection, 4 h after initiation of the infusion. We treated 3–6 patients at a particular dose level until the MTD was determined. Results: Overall, 44 patients received a total of 197 courses of therapy. Both drugs were given on days 1, 8 and 15 to 14 patients (68 courses). Delayed white blood cell recovery necessitated first protocol amendment to drop cyclophosphamide on days 8 and 15 in 9 patients (43 cycles). A second amendment was needed to drop gemcitabine on day 15 because of thrombocytopenia in 21 patients (86 courses). The dose-limiting toxicity was thrombocytopenia. The MTD of an optimal dose schedule was 800 mg/m² gemcitabine infused at a rate of 10 mg/m²/min on days 1 and 8, and 400 mg/m² cyclophosphamide, by intravenous piggyback injection, on day 1, 4 h after initiation of the gemcitabine infusion. Conclusions: The MTD can be given safely every 4 weeks to patients with MBC. Phase II studies are warranted to evaluate the clinical activity of this therapy.

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Section: Introductionmentioning

confidence: 99%

Phase I Study of Prolonged-Infusion Gemcitabine Combined with Cyclophosphamide in Patients with Metastatic Carcinoma of the Breast: Tolerability of an Optimal Dose Schedule

et al. 2009

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“…In the first line an objective response rate was obtained, ranging from 41 to 50% with a mild toxicity profile; in antracyclin-resistant patients it showed high activity, with a 15-33% clinical response [5]. Gemcitabine (G), is a pyrimidine nucleoside analogue showing activity and a relatively low toxicity as a second-line treatment for ABC [6,7].…”

Section: Introductionmentioning

confidence: 99%

Biweekly administration of gemcitabine and vinorelbine as first line therapy in elderly advanced breast cancer

Dinota

Bilancia

Romano

et al. 2005

Breast Cancer Res Treat

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“…As a result, a prolonged infusion time of 10 mg/m 2 /min may be preferable compared with a standard 30-minute infusion of GEM. To this regard, encouraging results have been observed in phase II trials evaluating FDR GEM either as single-agent or in combination regimens in various solid tumors, including breast cancer [18,19,20,21]. Moreover, a survival advantage was noted for FDR GEM compared with a 30-minute infusion in a randomized phase II study of patients undergoing first-line treatment for advanced adenocarcinoma of the pancreas [22].…”

Section: Introductionmentioning

confidence: 99%

Phase I–II trial of prolonged gemcitabine infusion plus paclitaxel as a biweekly schedule for advanced breast cancer patients pretreated with anthracyclines

Vici¹,

Fabi²,

Metro³

et al. 2010

Cancer Chemother Pharmacol

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Phase II trial of gemcitabine as prolonged infusion in metastatic breast cancer

Cited by 82 publications

References 0 publications

Phase I Study of Prolonged-Infusion Gemcitabine Combined with Cyclophosphamide in Patients with Metastatic Carcinoma of the Breast: Tolerability of an Optimal Dose Schedule

Phase I Study of Prolonged-Infusion Gemcitabine Combined with Cyclophosphamide in Patients with Metastatic Carcinoma of the Breast: Tolerability of an Optimal Dose Schedule

Biweekly administration of gemcitabine and vinorelbine as first line therapy in elderly advanced breast cancer

Phase I–II trial of prolonged gemcitabine infusion plus paclitaxel as a biweekly schedule for advanced breast cancer patients pretreated with anthracyclines

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