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Pegylated liposomal doxorubicin in combination with mitomycin C, infusional 5-fluorouracil and sodium folinic acid. A phase-I-study in patients with upper gastrointestinal cancer

Pegylated liposomal doxorubicin in combination with mitomycin C, infusional 5-fluorouracil and sodium folinic acid. A phase-I-study in patients with upper gastrointestinal cancer
Pegylated liposomal doxorubicin in combination with mitomycin C, infusional 5-fluorouracil and sodium folinic acid. A phase-I-study in patients with upper gastrointestinal cancer
Mitomycin C (MMC) in combination with infusional 5-fluorouracil (FU) plus folinic acid (FA) is an effective treatment for metastatic gastrointestinal cancer. Anthracyclines are commonly used in the treatment of upper gastrointestinal cancer. The aim of this study was to determine the maximum tolerated dose of liposomal, pegylated doxorubicin (Caelyx) in combination with infusional 5-FU/sodium FA and MMC. Escalating doses of Caelyx (15-25-30-35 mg m(-2) corresponding to dose levels I-IV) were applied on days 1 and 29, given to fixed doses of 24-h 5-FU (2000 mg m(-2)) and sodium FA (500 mg m(-2), mixed with 5-FU in one pump) weekly for 6 weeks, and MMC 7 mg m(-2) on days 8 and 36. At least three patients were treated at each dose level. A total of 25 patients are evaluable. No dose-limiting toxicity (DLT) was observed on level I (n=3). On level II, DLT occurred in three out of five patients (mucositis and leucopenia). Owing to the early DLTs at this dose, we added a 20 mg m(-2) Caelyx dose level (Ia). In total, 17 patients were treated at this dose level. Among these, only two patients experienced DLT in cycle one and 37 complete cycles have been administered in association with a low toxicity profile. The median dose intensity was 100% for each drug during the first course and no treatment delay exceeding 7 days was required. The recommended dose of 4-weekly Caelyx in combination with weekly 24-h 5-FU/sodium FA and 4-weekly MMC is 20 mg m(-2). Preliminary antitumour activity has been observed in patients with pretreated pancreatic cancer and in untreated gastric cancer
gastric cancer, infusional 5-fluorouracil, mitomycin C, pancreatic cancer, pegylated liposomal doxorubicin, sodium folinic acid
0007-0920
1893-1897
Hofheinz, R.D.
33f530fc-ba95-4369-8d21-f3dd8a35ac43
Willer, A.
a43400c4-a422-4288-80bb-efff27d26a93
Weisser, A.
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Gnad, U.
0a3b8eaa-e644-4158-bc5c-2c033f06563b
Saussele, S.
cac19778-5749-439c-b980-10d94b05a739
Kreil, S.
2404ac13-cdaa-43a3-913b-adceb79e598f
Hartmann, J.T.
74d9debc-b5fe-436b-83af-e5dc05de2f80
Hehlmann, R.
753d719b-7bf8-4f74-bfdc-6d5d47e5d2c7
Hochhaus, A.
4c0b9da4-adfa-4253-8af7-78cec9e9a24f
Hofheinz, R.D.
33f530fc-ba95-4369-8d21-f3dd8a35ac43
Willer, A.
a43400c4-a422-4288-80bb-efff27d26a93
Weisser, A.
63845a71-d2fd-474a-bbe1-3d32fff5f32a
Gnad, U.
0a3b8eaa-e644-4158-bc5c-2c033f06563b
Saussele, S.
cac19778-5749-439c-b980-10d94b05a739
Kreil, S.
2404ac13-cdaa-43a3-913b-adceb79e598f
Hartmann, J.T.
74d9debc-b5fe-436b-83af-e5dc05de2f80
Hehlmann, R.
753d719b-7bf8-4f74-bfdc-6d5d47e5d2c7
Hochhaus, A.
4c0b9da4-adfa-4253-8af7-78cec9e9a24f

Hofheinz, R.D., Willer, A., Weisser, A., Gnad, U., Saussele, S., Kreil, S., Hartmann, J.T., Hehlmann, R. and Hochhaus, A. (2004) Pegylated liposomal doxorubicin in combination with mitomycin C, infusional 5-fluorouracil and sodium folinic acid. A phase-I-study in patients with upper gastrointestinal cancer. British Journal of Cancer, 90 (10), 1893-1897. (doi:10.1038/sj.bjc.6601786).

Record type: Article

Abstract

Mitomycin C (MMC) in combination with infusional 5-fluorouracil (FU) plus folinic acid (FA) is an effective treatment for metastatic gastrointestinal cancer. Anthracyclines are commonly used in the treatment of upper gastrointestinal cancer. The aim of this study was to determine the maximum tolerated dose of liposomal, pegylated doxorubicin (Caelyx) in combination with infusional 5-FU/sodium FA and MMC. Escalating doses of Caelyx (15-25-30-35 mg m(-2) corresponding to dose levels I-IV) were applied on days 1 and 29, given to fixed doses of 24-h 5-FU (2000 mg m(-2)) and sodium FA (500 mg m(-2), mixed with 5-FU in one pump) weekly for 6 weeks, and MMC 7 mg m(-2) on days 8 and 36. At least three patients were treated at each dose level. A total of 25 patients are evaluable. No dose-limiting toxicity (DLT) was observed on level I (n=3). On level II, DLT occurred in three out of five patients (mucositis and leucopenia). Owing to the early DLTs at this dose, we added a 20 mg m(-2) Caelyx dose level (Ia). In total, 17 patients were treated at this dose level. Among these, only two patients experienced DLT in cycle one and 37 complete cycles have been administered in association with a low toxicity profile. The median dose intensity was 100% for each drug during the first course and no treatment delay exceeding 7 days was required. The recommended dose of 4-weekly Caelyx in combination with weekly 24-h 5-FU/sodium FA and 4-weekly MMC is 20 mg m(-2). Preliminary antitumour activity has been observed in patients with pretreated pancreatic cancer and in untreated gastric cancer

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More information

Published date: 13 April 2004
Keywords: gastric cancer, infusional 5-fluorouracil, mitomycin C, pancreatic cancer, pegylated liposomal doxorubicin, sodium folinic acid

Identifiers

Local EPrints ID: 59833
URI: http://eprints.soton.ac.uk/id/eprint/59833
ISSN: 0007-0920
PURE UUID: f7f51335-483c-4da0-ae1e-3a694e37999c

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Date deposited: 03 Sep 2008
Last modified: 15 Mar 2024 11:17

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Contributors

Author: R.D. Hofheinz
Author: A. Willer
Author: A. Weisser
Author: U. Gnad
Author: S. Saussele
Author: S. Kreil
Author: J.T. Hartmann
Author: R. Hehlmann
Author: A. Hochhaus

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