A multicenter phase II study of a five-day regimen of oral 5- fluorouracil plus eniluracil with or without leucovorin in patients with metastatic colorectal cancer

R. L. Schilsky, R. Bukowski, H. Burris, H. Hochster, M. O'Rourke, J. G. Wall, Sridhar Mani, T. Bonny, J. Levin, J. Hohneker

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Purpose: To evaluate the safety and efficacy of a five-day regimen of oral 5-fluorouracil (5-FU) plus eniluracil (776C85) in patients with metastatic colorectal cancer (CRC). Patients and methods: Seventy-five patients with metastatic CRC that was previously untreated or refractory to 5-FU-leucovorin (LV) were enrolled and divided into two strata based upon their treatment history. Twenty-four had not previously received chemotherapy or had received adjuvant chemotherapy that ended > 6 months prior to enrollment on study (previously untreated stratum). Fifty-one patients had disease refractory to intravenous (i.v.) 5-FU-LV (previously treated stratum). All patients received seven consecutive daily doses of eniluracil (20 mg/day) with once daily oral 5-FU given on days 2-6, repeated every four weeks. One-half of the patients in each stratum also received 50 mg/day oral LV on days 2-6. The 5-FU dose was 25 mg/m2 when administered without LV and 20 mg/m2 when administered with LV. Results: Partial response (PR) was noted in 2 of 12 patients receiving eniluracil-5-FU and in 3 of 12 patients receiving eniluracil-5-FU-LV in the previously untreated stratum. No responses were observed in the refractory disease stratum, however, 15 patients (30%) demonstrated stable disease over 2-18+ courses of therapy. Non-hematologic toxicities were mild; only 7% of patients experienced grade 3 diarrhea. Myelosuppression was frequent and dose limiting. Neutropenic sepsis was reported in 13.5% of patients. Conclusions: Eniluracil with 5-FU administered orally with or without LV on a five-day schedule is active and well tolerated when given as primary therapy to patients with metastatic CRC.

Original languageEnglish (US)
Pages (from-to)415-420
Number of pages6
JournalAnnals of Oncology
Volume11
Issue number4
DOIs
StatePublished - 2000
Externally publishedYes

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Leucovorin
Fluorouracil
Colorectal Neoplasms
eniluracil
Adjuvant Chemotherapy
Diarrhea
Sepsis
Appointments and Schedules
Therapeutics
History

Keywords

  • 5-fluorouracil
  • Colon cancer
  • Eniluracil

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A multicenter phase II study of a five-day regimen of oral 5- fluorouracil plus eniluracil with or without leucovorin in patients with metastatic colorectal cancer. / Schilsky, R. L.; Bukowski, R.; Burris, H.; Hochster, H.; O'Rourke, M.; Wall, J. G.; Mani, Sridhar; Bonny, T.; Levin, J.; Hohneker, J.

In: Annals of Oncology, Vol. 11, No. 4, 2000, p. 415-420.

Research output: Contribution to journalArticle

Schilsky, R. L. ; Bukowski, R. ; Burris, H. ; Hochster, H. ; O'Rourke, M. ; Wall, J. G. ; Mani, Sridhar ; Bonny, T. ; Levin, J. ; Hohneker, J. / A multicenter phase II study of a five-day regimen of oral 5- fluorouracil plus eniluracil with or without leucovorin in patients with metastatic colorectal cancer. In: Annals of Oncology. 2000 ; Vol. 11, No. 4. pp. 415-420.
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abstract = "Purpose: To evaluate the safety and efficacy of a five-day regimen of oral 5-fluorouracil (5-FU) plus eniluracil (776C85) in patients with metastatic colorectal cancer (CRC). Patients and methods: Seventy-five patients with metastatic CRC that was previously untreated or refractory to 5-FU-leucovorin (LV) were enrolled and divided into two strata based upon their treatment history. Twenty-four had not previously received chemotherapy or had received adjuvant chemotherapy that ended > 6 months prior to enrollment on study (previously untreated stratum). Fifty-one patients had disease refractory to intravenous (i.v.) 5-FU-LV (previously treated stratum). All patients received seven consecutive daily doses of eniluracil (20 mg/day) with once daily oral 5-FU given on days 2-6, repeated every four weeks. One-half of the patients in each stratum also received 50 mg/day oral LV on days 2-6. The 5-FU dose was 25 mg/m2 when administered without LV and 20 mg/m2 when administered with LV. Results: Partial response (PR) was noted in 2 of 12 patients receiving eniluracil-5-FU and in 3 of 12 patients receiving eniluracil-5-FU-LV in the previously untreated stratum. No responses were observed in the refractory disease stratum, however, 15 patients (30{\%}) demonstrated stable disease over 2-18+ courses of therapy. Non-hematologic toxicities were mild; only 7{\%} of patients experienced grade 3 diarrhea. Myelosuppression was frequent and dose limiting. Neutropenic sepsis was reported in 13.5{\%} of patients. Conclusions: Eniluracil with 5-FU administered orally with or without LV on a five-day schedule is active and well tolerated when given as primary therapy to patients with metastatic CRC.",
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T1 - A multicenter phase II study of a five-day regimen of oral 5- fluorouracil plus eniluracil with or without leucovorin in patients with metastatic colorectal cancer

AU - Schilsky, R. L.

AU - Bukowski, R.

AU - Burris, H.

AU - Hochster, H.

AU - O'Rourke, M.

AU - Wall, J. G.

AU - Mani, Sridhar

AU - Bonny, T.

AU - Levin, J.

AU - Hohneker, J.

PY - 2000

Y1 - 2000

N2 - Purpose: To evaluate the safety and efficacy of a five-day regimen of oral 5-fluorouracil (5-FU) plus eniluracil (776C85) in patients with metastatic colorectal cancer (CRC). Patients and methods: Seventy-five patients with metastatic CRC that was previously untreated or refractory to 5-FU-leucovorin (LV) were enrolled and divided into two strata based upon their treatment history. Twenty-four had not previously received chemotherapy or had received adjuvant chemotherapy that ended > 6 months prior to enrollment on study (previously untreated stratum). Fifty-one patients had disease refractory to intravenous (i.v.) 5-FU-LV (previously treated stratum). All patients received seven consecutive daily doses of eniluracil (20 mg/day) with once daily oral 5-FU given on days 2-6, repeated every four weeks. One-half of the patients in each stratum also received 50 mg/day oral LV on days 2-6. The 5-FU dose was 25 mg/m2 when administered without LV and 20 mg/m2 when administered with LV. Results: Partial response (PR) was noted in 2 of 12 patients receiving eniluracil-5-FU and in 3 of 12 patients receiving eniluracil-5-FU-LV in the previously untreated stratum. No responses were observed in the refractory disease stratum, however, 15 patients (30%) demonstrated stable disease over 2-18+ courses of therapy. Non-hematologic toxicities were mild; only 7% of patients experienced grade 3 diarrhea. Myelosuppression was frequent and dose limiting. Neutropenic sepsis was reported in 13.5% of patients. Conclusions: Eniluracil with 5-FU administered orally with or without LV on a five-day schedule is active and well tolerated when given as primary therapy to patients with metastatic CRC.

AB - Purpose: To evaluate the safety and efficacy of a five-day regimen of oral 5-fluorouracil (5-FU) plus eniluracil (776C85) in patients with metastatic colorectal cancer (CRC). Patients and methods: Seventy-five patients with metastatic CRC that was previously untreated or refractory to 5-FU-leucovorin (LV) were enrolled and divided into two strata based upon their treatment history. Twenty-four had not previously received chemotherapy or had received adjuvant chemotherapy that ended > 6 months prior to enrollment on study (previously untreated stratum). Fifty-one patients had disease refractory to intravenous (i.v.) 5-FU-LV (previously treated stratum). All patients received seven consecutive daily doses of eniluracil (20 mg/day) with once daily oral 5-FU given on days 2-6, repeated every four weeks. One-half of the patients in each stratum also received 50 mg/day oral LV on days 2-6. The 5-FU dose was 25 mg/m2 when administered without LV and 20 mg/m2 when administered with LV. Results: Partial response (PR) was noted in 2 of 12 patients receiving eniluracil-5-FU and in 3 of 12 patients receiving eniluracil-5-FU-LV in the previously untreated stratum. No responses were observed in the refractory disease stratum, however, 15 patients (30%) demonstrated stable disease over 2-18+ courses of therapy. Non-hematologic toxicities were mild; only 7% of patients experienced grade 3 diarrhea. Myelosuppression was frequent and dose limiting. Neutropenic sepsis was reported in 13.5% of patients. Conclusions: Eniluracil with 5-FU administered orally with or without LV on a five-day schedule is active and well tolerated when given as primary therapy to patients with metastatic CRC.

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KW - Colon cancer

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