Abstract | PURPOSE: METHODS: A clinical trial of parenteral, weekly, high-dose HU in combination with weekly, high-dose infusional fluorouracil ( 5FU) was initiated in patients with advanced pancreatic and gastric cancer. Patients received 5FU 1.3 g/m(2) by continuous intravenous infusion (CIVI) daily over 48 h weekly in combination with HU 4.3 g/m(2) CIVI per day over 48 h weekly. Patients also received the biologic agent interferon alfa-2a 9 MU subcutaneously (s.c.) three times per week and filgrastim 480 microg s.c. on days 3 (starting after midday), 4, 5, and 6 each week. Each cycle required treatment on days 1 and 8 every 22 days. RESULTS: Enrolled in the study were 32 patients, of whom 30 were evaluable. The median age was 56 years. Primary sites included pancreas (18), gastric (13) and islet cell (1). Despite filgrastim, the major toxicities were hematologic with 15 of 30 patients developing grade 3/4 granulocytopenia. Of the 30 patients, 4 developed grade 3/4 diarrhea. Interferon-mediated fatigue was mild. Of 12 evaluable patients with gastric cancer, 1 had a partial response, and there were no responders among patients with pancreatic cancer. CONCLUSIONS: Combined inhibition of RR and TS using this high-dose, weekly, 48-h infusional regimen is not an improvement over single-agent therapy in these tumor types.
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Authors | Andreas Kaubisch, Ron Kaleya, Hilda Haynes, Alla Rozenblit, Scott Wadler |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 53
Issue 4
Pg. 337-40
(Apr 2004)
ISSN: 0344-5704 [Print] Germany |
PMID | 14704829
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Recombinant Proteins
- Granulocyte Colony-Stimulating Factor
- Interferons
- Filgrastim
- Fluorouracil
- Hydroxyurea
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Drug Administration Schedule
- Female
- Filgrastim
- Fluorouracil
(administration & dosage, adverse effects)
- Granulocyte Colony-Stimulating Factor
(administration & dosage, adverse effects)
- Humans
- Hydroxyurea
(administration & dosage, adverse effects)
- Infusions, Intravenous
- Injections, Subcutaneous
- Interferons
(administration & dosage, adverse effects)
- Male
- Middle Aged
- Neoplasm Metastasis
- Neuroendocrine Tumors
(drug therapy, pathology)
- Pancreatic Neoplasms
(drug therapy, pathology)
- Recombinant Proteins
- Stomach Neoplasms
(drug therapy, pathology)
- Treatment Outcome
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