TY - JOUR
T1 - 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
T2 - A Southwest Oncology Group study
AU - Whitehead, Robert P.
AU - Benedetti, Jacqueline K.
AU - Abbruzzese, James L.
AU - Ardalan, Bach
AU - Williamson, Stephen
AU - Gaynor, Ellen R.
AU - Balcerzak, Stanley P.
AU - Macdonald, John S.
N1 - Funding Information:
This investigation was supported in part by the following PHS Cooperative Agreement grant numbers awarded by the National Cancer Institute, DHHS: CA38926, CA32102, CACA12644, CA46282, CA04920, CA32734, CA22433. CA12213, CA20319, CA58686.
PY - 2004/11
Y1 - 2004/11
N2 - 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/m 2 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/m 2 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.
AB - 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/m 2 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/m 2 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.
KW - 5-FU
KW - colorectal cancer
KW - leucovorin
KW - PALA
KW - Phase II
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U2 - 10.1023/B:DRUG.0000036689.28596.c6
DO - 10.1023/B:DRUG.0000036689.28596.c6
M3 - Article
C2 - 15292717
AN - SCOPUS:10244229731
VL - 22
SP - 467
EP - 473
JO - Investigational New Drugs
JF - Investigational New Drugs
SN - 0167-6997
IS - 4
ER -