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Docetaxel and cyclophosphamide in patients with advanced solid tumors
1University of Texas M. D. Anderson Cancer Center, Houston, USA.
Oncology (Williston Park, N.Y.)
|June 1, 1997
Summary
This study determined the maximum tolerated doses (MTDs) of docetaxel and cyclophosphamide for advanced solid tumors. Neutropenic fever was the primary dose-limiting toxicity, impacting 41% of patients.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Docetaxel and cyclophosphamide are commonly used chemotherapy agents.
- Establishing maximum tolerated doses (MTDs) is crucial for safe and effective phase II studies.
Purpose of the Study:
- To determine the MTD, toxicity, pharmacokinetics, and efficacy of docetaxel and cyclophosphamide combination therapy.
- To guide dose selection for future phase II clinical trials in patients with advanced solid tumors.
Main Methods:
- A phase I trial involving 39 patients with advanced solid tumors (26 with breast cancer).
- Doses of docetaxel ranged from 60-85 mg/m2 and cyclophosphamide from 600-800 mg/m2.
- Steroid prophylaxis was administered to all patients.
Main Results:
- MTDs were established as 75 mg/m2 docetaxel and 700 mg/m2 cyclophosphamide for previously treated patients.
- MTDs were 75 mg/m2 docetaxel and 800 mg/m2 cyclophosphamide for treatment-naive patients.
- Neutropenic fever was the dose-limiting toxicity (41% of patients, 13% of cycles). Granulocyte colony-stimulating factor (G-CSF) shortened neutropenia duration but did not allow dose escalation.
Conclusions:
- The MTDs for the combination of docetaxel and cyclophosphamide were defined.
- Neutropenic fever is a significant toxicity that needs careful management.
- These findings provide a basis for phase II trial dose selection.