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Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours
L C Pronk1, D Schrijvers, J H Schellens
1Rotterdam Cancer Institute (Dr Daniel den Hoed Kliniek) and University Hospital Rotterdam, The Netherlands.
British Journal of Cancer
|February 12, 1998
Summary
This phase I trial combined docetaxel and ifosfamide chemotherapy for solid tumors. A manageable dose of 75 mg/m² docetaxel with 5.0 g/m² ifosfamide was identified, favoring schedule A for future studies.
Area of Science:
- Oncology
- Clinical Pharmacology
- Cancer Chemotherapy
Background:
- Docetaxel and ifosfamide demonstrate significant activity in various solid tumors.
- Combination chemotherapy is a strategy to improve treatment efficacy.
- Phase I trials are crucial for assessing safety and determining optimal dosing for novel drug combinations.
Purpose of the Study:
- To evaluate the feasibility of combining docetaxel and ifosfamide.
- To determine the maximum tolerated dose (MTD) and safety profile of the combination.
- To establish a safe and effective schedule for subsequent phase II studies.
Main Methods:
- A phase I clinical trial involving 34 patients with advanced solid tumors.
- Two administration schedules were tested: docetaxel followed by ifosfamide (Schedule A), or ifosfamide followed by docetaxel (Schedule B).
- Dose escalation of docetaxel (60-85 mg/m²) and ifosfamide (2.5-5.0 g/m²) every 3 weeks.
Main Results:
- Grade 3/4 granulocytopenia was common (89%) but transient and dose-dependent.
- Febrile neutropenia (17%) and sepsis (2%) were observed.
- Non-hematological toxicities were generally mild to moderate; no significant pharmacokinetic interactions were noted. A complete response was seen in one patient with soft tissue sarcoma, and two partial responses were documented.
Conclusions:
- A combination dose of 75 mg/m² docetaxel and 5.0 g/m² ifosfamide is manageable.
- Schedule A (docetaxel followed by ifosfamide) is recommended for further investigation.
- The combination shows potential for treating solid tumors, warranting further phase II evaluation.