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A phase II pilot study of high-dose 24-hour continuous infusion of 5-FU and leucovorin and low-dose PALA for patients with colorectal cancer: A Southwest Oncology Group study

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Abstract

Purpose: The purpose of this phase II multi-institutional study was to define the efficacy and toxicity of infusional 5-FU in combination with PALA and leucovorin in patients with advanced colorectal cancer. Patients and methods: Patients were required to have histologically confirmed colorectal cancer with distant metastases. The treatment regimen consisted of 5-FU 2600 mg/m2 as a 24-hours continuous infusion given once a week, concurrently with leucovorin (LV) at 500 mg/m2 as a 24-hour continuous infusion. PALA was administered 24 hours prior to 5-FU/LV at a dose of 250 mg/m2 iv over 15 minutes weekly. Patients were continued on the assigned treatment regimen until progression of disease, unacceptable toxicity, or the patient declined further therapy. Results: This study accrued 28 patients and all were eligible and evaluable for toxicity. Four patients had inadequate assessment of response and are considered non-responders. There was one complete response and five partial responses for an overall response rate of 6/28 or 21% (95% confidence interval 8–41%). Estimated median survival was 17.4 months (95% confidence interval 13.3–20.5 months). One patient died of a treatment related infection. This patient also had grade 4 diarrhea and vomiting. Conclusion: The combination of 5-FU, leucovorin, and PALA in the doses and schedule used here, produces a response rate similar to other modulated schedules of 5-FU with similar survival and toxicity profiles.

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Authors and Affiliations

  1. University of Texas Medical Branch, Galveston, TX

    Robert P. Whitehead

  2. Southwest Oncology Group Statistical Center, Seattle, WA

    Jacqueline K. Benedetti

  3. University of Texas, MD Anderson Cancer Center, Houston, TX

    James L. Abbruzzese

  4. University of Miami, School of Medicine, Miami, FL

    Bach Ardalan

  5. University of Kansas Medical Center, Kansas City, KS

    Stephen Williamson

  6. Loyola University Stritch School of Medicine, Maywood, IL

    Ellen R. Gaynor

  7. Ohio State University Health Center, Columbus, OH

    Stanley P. Balcerzak

  8. St. Vincent's Comprehensive Cancer Center, New York, NY

    John S. Macdonald

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  1. Robert P. Whitehead
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  4. Bach Ardalan
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Whitehead, R.P., Benedetti, J.K., Abbruzzese, J.L. et al. A phase II pilot study of high-dose 24-hour continuous infusion of 5-FU and leucovorin and low-dose PALA for patients with colorectal cancer: A Southwest Oncology Group study. Invest New Drugs 22, 467–473 (2004). https://doi.org/10.1023/B:DRUG.0000036689.28596.c6

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