Phase I study of 5-fluorouracil administered by protracted venous infusion, leucovorin, and pelvic radiation therapy

James A. Martenson, Thomas G. Shanahan, Michael J. O'Connell, Charles D. Cobau, Georgene Schroeder, Patrick A. Burch, Ralph Levitt, Kendrith M. Rowland

Research output: Contribution to journalArticle

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Abstract

BACKGROUND. This study was designed to assess the toxicity of pelvic radiation therapy, 5-fluorouracil (5-FU) administered by protracted venous infusion, and leucovorin. METHODS. Pelvic radiation therapy consisted of 50.4-54 gray (Gy) administered in 28-30 fractions. Systemic treatment consisted of leucovorin (10 mg daily) administered orally and protracted venous infusion of 5-FU. The initial daily 5-FU dose was 150 mg/m2. Dose escalations were planned in increments of 25 mg/m2. RESULTS. Forty eligible patients were registered, of whom 37 were evaluable for chemoradiotherapy- related toxicity. Grade 3 or 4 toxicity secondary to radiation therapy, protracted venous infusion of 5-FU, and leucovorin occurred in 2 of 17 patients at a daily 5-FU dose of 150 mg/m2, in 5 of 10 patients at a daily 5-FU dose of 175 mg/m2, and in 5 of 10 patients at a daily 5-FU dose of 200 mg/m2. Diarrhea was dose-limiting in 7 of 8 patients with Grade 4 toxicity. Venous thrombosis, a treatment-related complication not directly related to chemotherapy or radiation therapy, occurred in 5 of the 40 patients entered into this study. Four thromboses occurred at the site of a central catheter. No thrombotic complications occurred in the last 7 patients, who were given warfarin orally (1 mg daily) during treatment. CONCLUSIONS. Toxicity due to radiation therapy, protracted venous infusion of 5-FU, and leucovorin when 5- FU is given daily at a dose of 150 mg/m2 is similar to that observed in current chemoradiotherapy regimens for patients with rectal carcinoma. This regimen will be considered as a possible investigational treatment arm of a future trial of adjuvant therapy for rectal carcinoma patients.

Original languageEnglish (US)
Pages (from-to)710-714
Number of pages5
JournalCancer
Volume86
Issue number4
DOIs
StatePublished - Aug 15 1999

Fingerprint

Leucovorin
Fluorouracil
Radiotherapy
Chemoradiotherapy
Carcinoma
Investigational Therapies
Warfarin
Therapeutics
Venous Thrombosis
Diarrhea
Thrombosis
Catheters
Drug Therapy

Keywords

  • 5-fluorouracil
  • Leucovorin
  • Pelvic radiation therapy
  • Protracted venous infusion
  • Rectal carcinoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Martenson, J. A., Shanahan, T. G., O'Connell, M. J., Cobau, C. D., Schroeder, G., Burch, P. A., ... Rowland, K. M. (1999). Phase I study of 5-fluorouracil administered by protracted venous infusion, leucovorin, and pelvic radiation therapy. Cancer, 86(4), 710-714. https://doi.org/10.1002/(SICI)1097-0142(19990815)86:4<710::AID-CNCR21>3.0.CO;2-5

Phase I study of 5-fluorouracil administered by protracted venous infusion, leucovorin, and pelvic radiation therapy. / Martenson, James A.; Shanahan, Thomas G.; O'Connell, Michael J.; Cobau, Charles D.; Schroeder, Georgene; Burch, Patrick A.; Levitt, Ralph; Rowland, Kendrith M.

In: Cancer, Vol. 86, No. 4, 15.08.1999, p. 710-714.

Research output: Contribution to journalArticle

Martenson, JA, Shanahan, TG, O'Connell, MJ, Cobau, CD, Schroeder, G, Burch, PA, Levitt, R & Rowland, KM 1999, 'Phase I study of 5-fluorouracil administered by protracted venous infusion, leucovorin, and pelvic radiation therapy', Cancer, vol. 86, no. 4, pp. 710-714. https://doi.org/10.1002/(SICI)1097-0142(19990815)86:4<710::AID-CNCR21>3.0.CO;2-5
Martenson, James A. ; Shanahan, Thomas G. ; O'Connell, Michael J. ; Cobau, Charles D. ; Schroeder, Georgene ; Burch, Patrick A. ; Levitt, Ralph ; Rowland, Kendrith M. / Phase I study of 5-fluorouracil administered by protracted venous infusion, leucovorin, and pelvic radiation therapy. In: Cancer. 1999 ; Vol. 86, No. 4. pp. 710-714.
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abstract = "BACKGROUND. This study was designed to assess the toxicity of pelvic radiation therapy, 5-fluorouracil (5-FU) administered by protracted venous infusion, and leucovorin. METHODS. Pelvic radiation therapy consisted of 50.4-54 gray (Gy) administered in 28-30 fractions. Systemic treatment consisted of leucovorin (10 mg daily) administered orally and protracted venous infusion of 5-FU. The initial daily 5-FU dose was 150 mg/m2. Dose escalations were planned in increments of 25 mg/m2. RESULTS. Forty eligible patients were registered, of whom 37 were evaluable for chemoradiotherapy- related toxicity. Grade 3 or 4 toxicity secondary to radiation therapy, protracted venous infusion of 5-FU, and leucovorin occurred in 2 of 17 patients at a daily 5-FU dose of 150 mg/m2, in 5 of 10 patients at a daily 5-FU dose of 175 mg/m2, and in 5 of 10 patients at a daily 5-FU dose of 200 mg/m2. Diarrhea was dose-limiting in 7 of 8 patients with Grade 4 toxicity. Venous thrombosis, a treatment-related complication not directly related to chemotherapy or radiation therapy, occurred in 5 of the 40 patients entered into this study. Four thromboses occurred at the site of a central catheter. No thrombotic complications occurred in the last 7 patients, who were given warfarin orally (1 mg daily) during treatment. CONCLUSIONS. Toxicity due to radiation therapy, protracted venous infusion of 5-FU, and leucovorin when 5- FU is given daily at a dose of 150 mg/m2 is similar to that observed in current chemoradiotherapy regimens for patients with rectal carcinoma. This regimen will be considered as a possible investigational treatment arm of a future trial of adjuvant therapy for rectal carcinoma patients.",
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T1 - Phase I study of 5-fluorouracil administered by protracted venous infusion, leucovorin, and pelvic radiation therapy

AU - Martenson, James A.

AU - Shanahan, Thomas G.

AU - O'Connell, Michael J.

AU - Cobau, Charles D.

AU - Schroeder, Georgene

AU - Burch, Patrick A.

AU - Levitt, Ralph

AU - Rowland, Kendrith M.

PY - 1999/8/15

Y1 - 1999/8/15

N2 - BACKGROUND. This study was designed to assess the toxicity of pelvic radiation therapy, 5-fluorouracil (5-FU) administered by protracted venous infusion, and leucovorin. METHODS. Pelvic radiation therapy consisted of 50.4-54 gray (Gy) administered in 28-30 fractions. Systemic treatment consisted of leucovorin (10 mg daily) administered orally and protracted venous infusion of 5-FU. The initial daily 5-FU dose was 150 mg/m2. Dose escalations were planned in increments of 25 mg/m2. RESULTS. Forty eligible patients were registered, of whom 37 were evaluable for chemoradiotherapy- related toxicity. Grade 3 or 4 toxicity secondary to radiation therapy, protracted venous infusion of 5-FU, and leucovorin occurred in 2 of 17 patients at a daily 5-FU dose of 150 mg/m2, in 5 of 10 patients at a daily 5-FU dose of 175 mg/m2, and in 5 of 10 patients at a daily 5-FU dose of 200 mg/m2. Diarrhea was dose-limiting in 7 of 8 patients with Grade 4 toxicity. Venous thrombosis, a treatment-related complication not directly related to chemotherapy or radiation therapy, occurred in 5 of the 40 patients entered into this study. Four thromboses occurred at the site of a central catheter. No thrombotic complications occurred in the last 7 patients, who were given warfarin orally (1 mg daily) during treatment. CONCLUSIONS. Toxicity due to radiation therapy, protracted venous infusion of 5-FU, and leucovorin when 5- FU is given daily at a dose of 150 mg/m2 is similar to that observed in current chemoradiotherapy regimens for patients with rectal carcinoma. This regimen will be considered as a possible investigational treatment arm of a future trial of adjuvant therapy for rectal carcinoma patients.

AB - BACKGROUND. This study was designed to assess the toxicity of pelvic radiation therapy, 5-fluorouracil (5-FU) administered by protracted venous infusion, and leucovorin. METHODS. Pelvic radiation therapy consisted of 50.4-54 gray (Gy) administered in 28-30 fractions. Systemic treatment consisted of leucovorin (10 mg daily) administered orally and protracted venous infusion of 5-FU. The initial daily 5-FU dose was 150 mg/m2. Dose escalations were planned in increments of 25 mg/m2. RESULTS. Forty eligible patients were registered, of whom 37 were evaluable for chemoradiotherapy- related toxicity. Grade 3 or 4 toxicity secondary to radiation therapy, protracted venous infusion of 5-FU, and leucovorin occurred in 2 of 17 patients at a daily 5-FU dose of 150 mg/m2, in 5 of 10 patients at a daily 5-FU dose of 175 mg/m2, and in 5 of 10 patients at a daily 5-FU dose of 200 mg/m2. Diarrhea was dose-limiting in 7 of 8 patients with Grade 4 toxicity. Venous thrombosis, a treatment-related complication not directly related to chemotherapy or radiation therapy, occurred in 5 of the 40 patients entered into this study. Four thromboses occurred at the site of a central catheter. No thrombotic complications occurred in the last 7 patients, who were given warfarin orally (1 mg daily) during treatment. CONCLUSIONS. Toxicity due to radiation therapy, protracted venous infusion of 5-FU, and leucovorin when 5- FU is given daily at a dose of 150 mg/m2 is similar to that observed in current chemoradiotherapy regimens for patients with rectal carcinoma. This regimen will be considered as a possible investigational treatment arm of a future trial of adjuvant therapy for rectal carcinoma patients.

KW - 5-fluorouracil

KW - Leucovorin

KW - Pelvic radiation therapy

KW - Protracted venous infusion

KW - Rectal carcinoma

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