Related Experiment Video
Updated: Aug 7, 2026
Establishment of a Primary Culture of Patient-derived Soft Tissue Sarcoma
Published on: April 11, 2018
Phase I/II study of docetaxel, ifosfamide, and doxorubicin in advanced, recurrent, or metastatic soft tissue sarcoma
Revathi Suppiah1, Laura Wood, Paul Elson
1Department of Hematology and Medical Oncology, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Desk R35, Cleveland, Ohio 44195, USA. suppiar@ccf.org
Background:
Based on reports of the efficacy of docetaxel (T) in STS, we undertook a phase I/II trial to determine the response rate (RR), dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of addition of T to doxorubicin (A) and ifosfamide (I) in advanced STS.
Methods:
Patients with advanced, recurrent, or metastatic STS, without prior chemotherapy, were enrolled in a dose escalation trial. Dose levels: I-A 40 mg/m(2); I 4.0 gm/m(2); T 40 mg/m(2), II-A 50; I 5.0; T 50, III-A 60; I 6.0; T 60, and IV-A 75; I 7.5; T 75. MTD was defined as the dose producing DLTs in >or=2 of 3-6 patients treated.
Results:
21 patients were accrued. Median age: 55 (28-78) years.
Histology:
leiomyosarcoma 10, spindle cell sarcoma 3, synovial sarcoma 2, angiosarcoma 1, fibrous histiocytoma 1, epitheliod hemangio-endothelioma 1, and 3 not specified. MTD was level III (A 60, I 6.0, and T 60). DLT was myelosuppression. All grade 4 toxicities were hematologic. Patients received median 2 cycles (range 2-9). Eight patients (38%) achieved partial response (PR). PR occurred after six cycles in 5 patients. 18 patients died. Median overall survival: 17 months (95% CI, 9.1-33.6 months).
Conclusions:
The recommended Phase II dose of this combination is level III: A 60 mg/m(2), I 6.0 g/m(2), T 60 mg/m(2), with mesna and granulocyte-colony stimulating factor. The RR is similar to that of AI in other trials, but the survival is better than anticipated.
