Related Experiment Video
Updated: Jul 17, 2026

Establishment of a Primary Culture of Patient-derived Soft Tissue Sarcoma
Published on: April 11, 2018
A Phase II Study of Flavopiridol in Patients With Previously Untreated Advanced Soft Tissue Sarcoma
Don G Morris1, Vivien H C Bramwell, Robert Turcotte
1Department of Medicine, Tom Baker Cancer Centre, University of Calgary, Alberta, Canada T2N 4N2.
Abstract:
Purpose. Flavopiridol is a potent cyclin-dependent kinase (CDK) inhibitor that has preclinical activity in many tumours. This synthetic flavonoid was tested in a phase II nonrandomized, nonblinded multicentre clinical trial to determine its activity and toxicity in patients with previously untreated metastatic or locally advanced soft tissue sarcoma. Methods. A total of 18 patients with histologically confirmed nonoperable soft tissue was treated with flavopiridol administered at a dose of 50 mg/m(2) IV over 1 hour daily x3 days every 3 weeks. Results. Eighteen patients were accrued to the study over a period of 6 months. No objective responses were noted in the seventeen evaluable patients. Eight patients (47%) exhibited stable disease after 2 cycles (median duration of 4.3 months (range 1.4-6.9 months). Kaplan-Meier estimates for 3- and 6-month progression-free survivial rates were 44 percent and 22 percent, respectively. The only grade 3 toxicities were diarrhea (N = 2), nausea (N = 2), gastritis (N = 1), and fatigue (N = 1). Ninety-four percent of patients received >/= 90% of the planned dose intensity, during 55 treatment cycles. Conclusions. Flavopiridol was well tolerated at the dose and schedule used in this study, however, no objective treatment responses were seen and thus our results do not support further exploration of flavopiridol as a monotherapy at this dose and schedule in soft tissue sarcomas.
Insights
Flavopiridol, a cyclin-dependent kinase (CDK) inhibitor, showed no objective responses in soft tissue sarcoma patients. While well-tolerated, it does not support further investigation as a monotherapy.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Flavopiridol is a potent cyclin-dependent kinase (CDK) inhibitor with demonstrated preclinical anti-cancer activity.
- Soft tissue sarcoma is a group of rare cancers that can be locally advanced or metastatic.
Purpose of the Study:
- To evaluate the activity and toxicity of flavopiridol in patients with previously untreated metastatic or locally advanced soft tissue sarcoma.
- To determine the optimal dose and schedule for flavopiridol in this patient population.
Main Methods:
- A phase II, nonrandomized, nonblinded, multicenter clinical trial was conducted.
- Eighteen patients with soft tissue sarcoma received flavopiridol at 50 mg/m(2) intravenously over 1 hour daily for 3 days every 3 weeks.
Main Results:
- No objective responses were observed in the 17 evaluable patients.
- Forty-seven percent of patients achieved stable disease for a median duration of 4.3 months.
- Grade 3 toxicities included diarrhea, nausea, gastritis, and fatigue. Flavopiridol was well tolerated, with 94% of patients receiving 90% of the planned dose intensity.
Conclusions:
- Flavopiridol was well tolerated at the tested dose and schedule in patients with soft tissue sarcoma.
- The lack of objective responses suggests that flavopiridol as a monotherapy is not effective for this indication at this dose and schedule.
- Further exploration of flavopiridol as a monotherapy in soft tissue sarcomas is not supported by these findings.
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