Phase I trial of dose-intense liposome-encapsulated doxorubicin in patients with advanced sarcoma.

1997 ◽  
Vol 15 (5) ◽  
pp. 2111-2117 ◽  
Author(s):  
E S Casper ◽  
G K Schwartz ◽  
A Sugarman ◽  
D Leung ◽  
M F Brennan
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Phase I ◽  
Phase I Trial ◽  
Phase Ii Trial ◽  
Dose Intensity ◽  
Maximum Tolerated Dose ◽  
Advanced Soft Tissue Sarcoma ◽  
Stimulating Factor ◽  
Specific Phase

PURPOSE To define the maximum-tolerated dose (MTD) of liposome-encapsulated doxorubicin (LED) when used every 2 weeks with granulocyte colony-stimulating factor (G-CSF) in patients with advanced soft tissue sarcoma. PATIENTS AND METHODS Doxorubicin encapsulated in egg phosphatidylcholine/cholesterol liposomes was given to patients with sarcoma in a disease-specific phase I trial. The initial dose was 75 mg/m2 with G-CSF 5 micrograms/kg. The MTD was defined as the highest dose that could be given every 2 weeks. RESULTS Twenty-nine patients participated in this study. Major toxicities included myelosuppression, nausea and vomiting, fatigue, and mucositis. Eight patients were hospitalized for nadir fever. No cardiotoxicity was seen. The MTD was LED 105 mg/m2 with G-CSF 5 micrograms/kg. LED 120 mg/m2 resulted in tolerable, albeit prominent, acute toxicity, but did not permit recycling of therapy on day 15. Among 26 patients with soft tissue sarcoma, 23 had measurable disease, of whom three achieved a partial response (13%; 95% confidence interval, 2% to 34%). CONCLUSION LED can be administered every 2 weeks at a dose of 105 mg/m2 with G-CSF support, which provides a dose-intensity of 52.5 mg/m2/wk. To exceed this intensity, the dose of LED that would have to be administered every 3 weeks would be greater than 157.5 mg/m2. A formal phase II trial is needed to estimate better the true response rate.

scholarly journals Phase I Trial of Neoadjuvant Conformal Radiotherapy Plus Sorafenib for Patients with Locally Advanced Soft Tissue Sarcoma of the Extremity

2014 ◽  
Vol 21 (5) ◽  
pp. 1616-1623 ◽  
Author(s):  
Robert J. Canter ◽  
Dariusz Borys ◽  
Abimbola Olusanya ◽  
Chin-Shang Li ◽  
Li-Yuan Lee ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Phase I ◽  
Phase I Trial ◽  
Locally Advanced ◽  
Conformal Radiotherapy ◽  
Advanced Soft Tissue Sarcoma

Phase I-II Trial of Intensification of the MAID Regimen With Support of Lenograstim (rHuG-CSF) in Patients With Advanced Soft-Tissue Sarcoma (STS)

1999 ◽  
Vol 22 (3) ◽  
pp. 267-272 ◽  
Author(s):  
Christine Chevreau ◽  
Binh Nguyen Bui ◽  
Bernard Chevallier ◽  
Ivan Krakowski ◽  
Christine Maugard ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Phase I ◽  
Advanced Soft Tissue Sarcoma

Phase I–II trial of intensification of the maid regimen with lenograstim (rHuG-CSF) in patients (pts) with advanced soft tissue sarcoma (STS)

1993 ◽  
Vol 29 ◽  
pp. S57
Author(s):  
B.N. Bui ◽  
C. Chevreau ◽  
B. Chevallier ◽  
I. Krakowski ◽  
C. Louboutin ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Phase I ◽  
Advanced Soft Tissue Sarcoma

A phase II trial of PALA+dipyridamole in patients with advanced soft-tissue sarcoma

1991 ◽  
Vol 28 (1) ◽  
pp. 51-54 ◽  
Author(s):  
Ephraim S. Casper ◽  
Jose Baselga ◽  
Tracy B. Smart ◽  
Gordon B. Magill ◽  
Maurie Markman ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Advanced Soft Tissue Sarcoma

Phase I study of high-dose piroxantrone with granulocyte colony-stimulating factor.

1993 ◽  
Vol 11 (9) ◽  
pp. 1795-1803 ◽  
Author(s):  
D M Savarese ◽  
A M Denicoff ◽  
S L Berg ◽  
M Hillig ◽  
S P Baker ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Dose Intensity ◽  
Maximum Tolerated Dose ◽  
High Dose ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Nonhematologic Toxicity ◽  
Stimulating Factor ◽  
Dose Limiting Toxicity

PURPOSE We performed a phase I trial of piroxantrone with and without granulocyte colony-stimulating factor (G-CSF) to determine whether the use of this cytokine would enable us to increase the dose-intensity of piroxantrone. PATIENTS AND METHODS Thirty-eight patients received 121 courses of piroxantrone administered once every 21 days. Initial patient cohorts received piroxantrone alone starting at 150 mg/m2 and the dose was escalated in subsequent patients until dose-limiting toxicity (DLT) was reached. Patient cohorts then received escalating doses of piroxantrone starting at 185 mg/m2 administered with G-CSF beginning day 2. RESULTS Dose-limiting neutropenia occurred in three of six patients treated with 185 mg/m2 piroxantrone; the maximum-tolerated dose (MTD) of piroxantrone alone was 150 mg/m2. Three of six patients treated with piroxantrone and G-CSF exhibited dose-limiting thrombocytopenia at 445 mg/m2; the MTD of piroxantrone with G-CSF was thus 355 mg/m2. Seven patients developed symptomatic congestive heart failure (CHF) at cumulative piroxantrone doses ranging from 855 to 2,475 mg/m2 and two have died of cardiotoxicity. Of these patients, six of seven had previously received doxorubicin. Other nonhematologic toxicity was mild. CONCLUSION The use of G-CSF results in a more than twofold increase in the MTD of piroxantrone. However, symptomatic cardiotoxicity is prominent, especially in patients who have received prior treatment with anthracyclines.

Phase I study of NBTXR3 nanoparticles, in patients with advanced soft tissue sarcoma (STS).

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 10563-10563 ◽  
Author(s):  
Sylvie Bonvalot ◽  
Cecile Le Pechoux ◽  
Thierry De Baere ◽  
Xavier Buy ◽  
Antoine Italiano ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Phase I ◽  
Phase I Study ◽  
Advanced Soft Tissue Sarcoma

Phase I Trial of Preoperative Doxorubicin-Based Concurrent Chemoradiation and Surgical Resection for Localized Extremity and Body Wall Soft Tissue Sarcomas

2004 ◽  
Vol 22 (16) ◽  
pp. 3375-3380 ◽  
Author(s):  
Peter W.T. Pisters ◽  
Shreyaskumar R. Patel ◽  
Victor G. Prieto ◽  
Peter F. Thall ◽  
Valerae O. Lewis ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Phase I ◽  
Continuous Infusion ◽  
Surgical Resection ◽  
Phase I Trial ◽  
Body Wall ◽  
Soft Tissue Sarcomas ◽  
Maximum Tolerated Dose ◽  
External Beam Radiation ◽  
Preoperative Radiation

Purpose The primary objective of this phase I trial was to define the maximum-tolerated dose of continuous-infusion doxorubicin administered with standard preoperative radiation for patients with localized, potentially resectable soft tissue sarcomas of the extremities or body wall. Patients and Methods Twenty-seven patients with radiographically resectable intermediate- or high-grade soft tissue sarcomas were treated. Preoperative external-beam radiation was administered in 25 2-Gy fractions (total dose, 50 Gy). Concurrent continuous-infusion doxorubicin was administered by an initial bolus (4 mg/m2) and subsequent 4-day continuous infusion (12.5, 15.0, 17.5, or 20.0 mg/m2/wk). Radiographic restaging was performed 4 to 7 weeks after chemoradiation, and patients with localized disease underwent surgical resection. Results Chemoradiation was completed as an outpatient procedure in 25 patients (93%). The maximum-tolerated dose of continuous-infusion doxorubicin combined with standard preoperative radiation was 17.5 mg/m2/wk; at this dose level, seven (30%) of 23 patients had grade 3 dermatologic toxicity. Macroscopically complete resection (R0 or R1) was performed in all 26 patients who underwent surgery. Among 22 patients who were treated with doxorubicin 17.5/mg/m2/wk with concurrent radiation and subsequent surgery, 11 patients (50%) had 90% or greater tumor necrosis, including two patients who had complete pathologic responses. Conclusion Preoperative doxorubicin-based chemoradiation appears safe and feasible. The maximum-tolerated dose of continuous-infusion doxorubicin with standard preoperative radiation was 17.5 mg/m2/wk. Pathologic response rates with this regimen are encouraging.

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