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Updated: Jul 4, 2026
Establishment of a Primary Culture of Patient-derived Soft Tissue Sarcoma
Published on: April 11, 2018
Phase II Study of Paclitaxel in Patients With Soft Tissue Sarcomas
S R Patel1, K A Linke, M A Burgess
1Department of Melanoma/Sarcoma Medical Oncology MD Anderson Cancer Center University of Texas PO Box 77, 1515 Holcombe Blvd Houston TX 77030 USA.
Abstract:
Purpose. Patients with soft tissue sarcoma (STS) who have previously received standard chemotherapy including adriamycin (doxorubicin), ifosfamide, cyclophosphamide and DTIC (dacarbazine) have very limited therapeutic options. It is important to identify new drugs with some activity in this disease and we therefore undertook this trial to determine the antitumor activity of paclitaxel (Taxol).Methods. We conducted a phase II study of paclitaxel in patients with STS who had received prior standard chemotherapy. Paclitaxel was administered at a starting dose of 200 mg m(-2) as a 24-h infusion with STS premedication, every 21 days or upon hematologic recovery (absolute granulocyte count (AGC) >/= 1500/mul, platelets >/= 100 000/mul). Neupogen was not used routinely. The study was conducted based on a two-stage design proposed by Simon. Responses were assessed radiographically using standard criteria.Results. Nineteen eligible patients were treated in the first stage of the study. The median age was 50 years (range 20-68 years), and there were nine females and 10 males with Zubrod performance status of 1 or 2. One patient achieved a minor response. Median AGC nadir was 0.1/mul on day 12 with absolute neutropenia lasting 5 days. Median platelet nadir was 171 000/mul on day 9. There were no grade 3/4 non-hematologic toxicities and no deaths related to treatment.Discussion. Paclitaxel, at this dose and schedule, is well tolerated but inactive in this patient population.
Insights
Paclitaxel (Taxol) showed limited antitumor activity in patients with advanced soft tissue sarcoma (STS) previously treated with standard chemotherapy. The drug was well-tolerated, but did not demonstrate significant efficacy in this difficult-to-treat population.
Area of Science:
- Oncology
- Pharmacology
Background:
- Soft tissue sarcoma (STS) patients often have limited treatment options after standard chemotherapy.
- Identifying novel therapeutic agents with activity in advanced STS is crucial.
Purpose of the Study:
- To evaluate the antitumor activity of paclitaxel (Taxol) in patients with advanced STS.
- To assess the safety and tolerability of paclitaxel in this patient population.
Main Methods:
- A phase II clinical trial was conducted.
- Paclitaxel was administered at 200 mg/m² as a 24-hour infusion every 21 days.
- Radiographic assessment was used to determine treatment response.
Main Results:
- Nineteen patients with previously treated STS were enrolled.
- Only one patient achieved a minor response.
- Paclitaxel was well-tolerated with no grade 3/4 non-hematologic toxicities.
Conclusions:
- Paclitaxel at the tested dose and schedule demonstrated limited efficacy in patients with advanced STS.
- The drug is well-tolerated but inactive in this patient population, suggesting it is not a viable option for pre-treated STS.
