Abstract
Aims and background: To evaluate the toxicity of high-dose ifosfamide in ovarian cancer patients refractory or resistant to platinum and/or paclitaxel-containing chemotherapy. Methods: This was an open, non-randomized phase I-II trial of high-dose ifosfamide. Eligibility criteria were: patients aged 18-75 years affected by ovarian cancer with refractory or resistant disease or early relapse after first-line treatment including platinum or paclitaxel. Three patients were given escalating ifosfamide doses; if no severe adverse events occurred, the ifosfamide dose was increased. The starting dose of ifosfamide was 10 g/m 2 iv and the dose increase was 1 g/m 2 every four weeks for a total of five courses; 12 g/m 2 was the maximum ifosfamide dose to be administered. The trial then progressed to a phase II trial, in which ifosfamide was given at the maximum tolerated dose reached during the escalating dose phase. Results: A total of 36 patients entered the trial. Nine patients were involved in phase I of the study; 3 received 10 g/m 2 ifosfamide, 3 11 g/m 2 and 3 12 g/m 2. Of the 32 evaluable patients 6 (18.8%) achieved a complete response and three (9.4%) a partial response, giving an overall response rate of 28.1% (95% CI, 15-61% based on Poisson's approximation). The median number of ifosfamide courses was five. G1, G2 and G3 neurotoxicity was reported in 3 (8%), 2 (5%) and 2 (5%) patients, respectively. Conclusion: This phase I-II trial indicates that high-dose ifosfamide has some activity but also a relevant degree of toxicity in resistant or refractory platinum and paclitaxel-pretreated ovarian cancer.
| Original language | English |
|---|---|
| Pages (from-to) | 217-219 |
| Number of pages | 3 |
| Journal | Tumori |
| Volume | 85 |
| Issue number | 4 |
| Publication status | Published - Jul 1999 |
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Keywords
- Chemotherapy
- Ifosfamide
- Ovarian cancer
- Recurrence
ASJC Scopus subject areas
- Cancer Research
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A phase I-II trial of high-dose ifosfamide in patients with ovarian cancer refractory or resistant to platinum and/or paclitaxel-containing chemotherapy. / Scarfone, Giovanna; Villa, Antonella; Parazzini, Fabio; Sciatta, Cesarina; Polverino, Giampiero; Bolis, Giorgio.
In: Tumori, Vol. 85, No. 4, 07.1999, p. 217-219.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A phase I-II trial of high-dose ifosfamide in patients with ovarian cancer refractory or resistant to platinum and/or paclitaxel-containing chemotherapy
AU - Scarfone, Giovanna
AU - Villa, Antonella
AU - Parazzini, Fabio
AU - Sciatta, Cesarina
AU - Polverino, Giampiero
AU - Bolis, Giorgio
PY - 1999/7
Y1 - 1999/7
N2 - Aims and background: To evaluate the toxicity of high-dose ifosfamide in ovarian cancer patients refractory or resistant to platinum and/or paclitaxel-containing chemotherapy. Methods: This was an open, non-randomized phase I-II trial of high-dose ifosfamide. Eligibility criteria were: patients aged 18-75 years affected by ovarian cancer with refractory or resistant disease or early relapse after first-line treatment including platinum or paclitaxel. Three patients were given escalating ifosfamide doses; if no severe adverse events occurred, the ifosfamide dose was increased. The starting dose of ifosfamide was 10 g/m 2 iv and the dose increase was 1 g/m 2 every four weeks for a total of five courses; 12 g/m 2 was the maximum ifosfamide dose to be administered. The trial then progressed to a phase II trial, in which ifosfamide was given at the maximum tolerated dose reached during the escalating dose phase. Results: A total of 36 patients entered the trial. Nine patients were involved in phase I of the study; 3 received 10 g/m 2 ifosfamide, 3 11 g/m 2 and 3 12 g/m 2. Of the 32 evaluable patients 6 (18.8%) achieved a complete response and three (9.4%) a partial response, giving an overall response rate of 28.1% (95% CI, 15-61% based on Poisson's approximation). The median number of ifosfamide courses was five. G1, G2 and G3 neurotoxicity was reported in 3 (8%), 2 (5%) and 2 (5%) patients, respectively. Conclusion: This phase I-II trial indicates that high-dose ifosfamide has some activity but also a relevant degree of toxicity in resistant or refractory platinum and paclitaxel-pretreated ovarian cancer.
AB - Aims and background: To evaluate the toxicity of high-dose ifosfamide in ovarian cancer patients refractory or resistant to platinum and/or paclitaxel-containing chemotherapy. Methods: This was an open, non-randomized phase I-II trial of high-dose ifosfamide. Eligibility criteria were: patients aged 18-75 years affected by ovarian cancer with refractory or resistant disease or early relapse after first-line treatment including platinum or paclitaxel. Three patients were given escalating ifosfamide doses; if no severe adverse events occurred, the ifosfamide dose was increased. The starting dose of ifosfamide was 10 g/m 2 iv and the dose increase was 1 g/m 2 every four weeks for a total of five courses; 12 g/m 2 was the maximum ifosfamide dose to be administered. The trial then progressed to a phase II trial, in which ifosfamide was given at the maximum tolerated dose reached during the escalating dose phase. Results: A total of 36 patients entered the trial. Nine patients were involved in phase I of the study; 3 received 10 g/m 2 ifosfamide, 3 11 g/m 2 and 3 12 g/m 2. Of the 32 evaluable patients 6 (18.8%) achieved a complete response and three (9.4%) a partial response, giving an overall response rate of 28.1% (95% CI, 15-61% based on Poisson's approximation). The median number of ifosfamide courses was five. G1, G2 and G3 neurotoxicity was reported in 3 (8%), 2 (5%) and 2 (5%) patients, respectively. Conclusion: This phase I-II trial indicates that high-dose ifosfamide has some activity but also a relevant degree of toxicity in resistant or refractory platinum and paclitaxel-pretreated ovarian cancer.
KW - Chemotherapy
KW - Ifosfamide
KW - Ovarian cancer
KW - Recurrence
UR - http://www.scopus.com/inward/record.url?scp=0032840444&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032840444&partnerID=8YFLogxK
M3 - Article
C2 - 10587020
AN - SCOPUS:0032840444
VL - 85
SP - 217
EP - 219
JO - Tumori
JF - Tumori
SN - 0300-8916
IS - 4
ER -