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/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.
| Original language | English |
|---|---|
| Pages (from-to) | 467-473 |
| Number of pages | 7 |
| Journal | Investigational New Drugs |
| Volume | 22 |
| Issue number | 4 |
| DOIs | |
| State | Published - Nov 1 2004 |
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Keywords
- 5-FU
- colorectal cancer
- leucovorin
- PALA
- Phase II
ASJC Scopus subject areas
- Molecular Medicine
- Pharmacology
Cite this
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. / Whitehead, Robert P.; Benedetti, Jacqueline K.; Abbruzzese, James L.; Ardalan, Bach; Williamson, Stephen; Gaynor, Ellen R.; Balcerzak, Stanley P.; Macdonald, John S.
In: Investigational New Drugs, Vol. 22, No. 4, 01.11.2004, p. 467-473.Research output: Contribution to journal › Article
}
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.
PY - 2004/11/1
Y1 - 2004/11/1
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
UR - http://www.scopus.com/inward/record.url?scp=10244229731&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=10244229731&partnerID=8YFLogxK
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 -