scholarly journals Phase II study of continuous-infusion high-dose ifosfamide in advanced and/or metastatic pretreated soft tissue sarcomas

1997 ◽  
Vol 8 (11) ◽  
pp. 1159-1162 ◽  
Author(s):  
R. Palumbo ◽  
S. Palmeri ◽  
M. Antimi ◽  
C. Gatti ◽  
P. Raffo ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Continuous Infusion ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Soft Tissue Sarcomas ◽  
High Dose

High-dose ifosfamide in bone and soft tissue sarcomas: results of phase II and pilot studies--dose-response and schedule dependence.

1997 ◽  
Vol 15 (6) ◽  
pp. 2378-2384 ◽  
Author(s):  
S R Patel ◽  
S Vadhan-Raj ◽  
N Papadopolous ◽  
C Plager ◽  
M A Burgess ◽  
...  
Keyword(s):  
Pilot Study ◽  
Soft Tissue ◽  
Continuous Infusion ◽  
Phase Ii ◽  
Dose Response ◽  
Overall Response Rate ◽  
Response Rate ◽  
Soft Tissue Sarcomas ◽  
High Dose ◽  
Grade 3

PURPOSE To evaluate the efficacy and feasibility of high-dose ifosfamide (HDI) at a total dose of 14 g/m2 per cycle with mesna in combination with granulocyte colony-stimulating factor (G-CSF) in adult patients with sarcomas. PATIENTS AND METHODS Between July 1991 and February 1994, 74 patients with sarcomas (37 bone and 37 soft tissue) were treated on two simultaneous phase II studies that evaluated HDI given as a continuous infusion over 74 hours. G-CSF was started on day 5 at 5 microg/kg/d until recovery of granulocyte count. Additionally, between March 1993 and March 1994, 15 similar patients with previously treated bone or soft tissue sarcomas were treated on a pilot study in which the same total dose of ifosfamide was administered by a bolus schedule, along with mesna and G-CSF. Patients were treated until maximal response, and where possible, surgical resection of gross disease was performed. RESULTS Seventy-two patients from the phase II study using continuous infusion are assessable for response. Four complete responses (CRs) and 17 partial responses (PRs) were noted, for an overall response rate of 29% (95% confidence interval [CI], 19% to 39%). The response rate was 40% (95% CI, 24% to 56%) for bone sarcomas and 19% (95% CI, 6% to 32%) for soft tissue sarcomas. Fourteen patients from the pilot study that used a bolus schedule are assessable for response. One CR and seven PRs were noted, for an overall response rate of 57% (95% CI, 31% to 83%) and a response rate of 45% for soft tissue sarcomas. Two patients developed grade 3 to 4 renal toxicity, three developed grade 3 CNS toxicity, one had possible grade 3 cardiac toxicity, and two developed severe painful peripheral neuropathy. There were no treatment-related deaths. CONCLUSION HDI at 14 g/m2 with mesna and G-CSF is an active salvage regimen for patients with bone and soft tissue sarcomas. There is a definite positive dose-response curve, and bolus administration appears to be more active than continuous infusion.

Effect of high-dose ifosfamide in advanced soft tissue sarcomas. A multicentre phase II study of the EORTC Soft Tissue and Bone Sarcoma Group

2000 ◽  
Vol 36 (1) ◽  
pp. 61-67 ◽  
Author(s):  
O.S. Nielsen ◽  
I. Judson ◽  
Q. van Hoesel ◽  
A. le Cesne ◽  
H.J. Keizer ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Soft Tissue Sarcomas ◽  
Bone Sarcoma ◽  
High Dose ◽  
Multicentre Phase

scholarly journals Phase II Trial of Doxorubicin Plus Escalated High-Dose Ifosfamide in Patients With Advanced Soft Tissue Sarcomas of the Adult: A Study of the Spanish Group for Research on Sarcomas (GEIS)

Sarcoma ◽  
2006 ◽  
Vol 2006 ◽  
pp. 1-8 ◽  
Author(s):  
A. López-Pousa ◽  
J. Martín ◽  
J. Montalar ◽  
R. de las Peñas ◽  
J. García del Muro ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Febrile Neutropenia ◽  
Continuous Infusion ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Soft Tissue Sarcomas ◽  
High Dose ◽  
Substantial Toxicity ◽  
Grade 3

Background.To explore the tolerance and the activity of high-dose ifosfamide (IFOS) combined with doxorubicin (DXR) at 50 mg/m2every 4 weeks in patients with soft tissue sarcomas.Methods.DXR was given IV bolus and IFOS by continuous infusion at 2 g/m2/day. Initial IFOS dose (12 g/m2) was adjusted to 10, 13, or 14 g/m2according to toxicity.Results.Seventy patients received 277 cycles (median 3 cycles, range 1–10), 34% with IFOS dose increased, 30% decreased, and 48% delivered at 12 g/m2. Toxicity grade 4 occurred on granulocytes (67% of patients) or platelets (19%), 54% had febrile neutropenia, 31% grade 3/4 asthenia, and 26% abandoned the study due to toxicity. Three toxic deaths occurred. In 57 non-GIST patients objective activity was 45.6% (95% CI, 32 to 58%).Conclusion.At least 4 cycles were tolerated by 71% of patients, most receiving DXR 50 mg/m2plus IFOS 10–12 g/m2, with substantial toxicity.

scholarly journals Phase II study with Docetaxel (Taxotere®) in advanced soft tissue sarcomas of the adult

1994 ◽  
Vol 5 (6) ◽  
pp. 539-542 ◽  
Author(s):  
Q.G.C. M. van Hoesel ◽  
J. Verweij ◽  
G. Catimel ◽  
M. Clavel ◽  
P. Kerbrat ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Soft Tissue Sarcomas
Sign in / Sign up

Export Citation Format

Share Document