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Cisplatin-paclitaxel weekly schedule in advanced solid tumors: a phase I study
G Frasci1, P Comella, A Parziale
1Division of Medical Oncology A, National Tumor Institute of Naples, Italy.
Summary
This study determined maximum tolerable doses for weekly paclitaxel and cisplatin in advanced cancers. Adding G-CSF support increased tolerable doses for both chemotherapy drugs, showing a safe and effective treatment approach.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Advanced solid neoplasms often require combination chemotherapy.
- Determining maximum tolerable doses (MTDs) is crucial for optimizing treatment regimens.
- Paclitaxel and cisplatin are widely used chemotherapeutic agents.
Purpose of the Study:
- To establish the MTDs of paclitaxel and cisplatin administered weekly.
- To evaluate the MTDs when given alone or concurrently with G-CSF.
- To assess safety and tolerability in patients with advanced solid tumors.
Main Methods:
- A dose-escalation study was conducted in patients with advanced cancer.
- Paclitaxel and cisplatin were administered weekly, with doses escalated until dose-limiting toxicity (DLT).
- Granulocyte-colony stimulating factor (G-CSF) was administered to some patients.
Main Results:
- MTDs were 30 mg/m²/week for cisplatin and 65 mg/m²/week for paclitaxel without G-CSF.
- MTDs increased to 40 mg/m²/week for cisplatin and 85 mg/m²/week for paclitaxel with G-CSF support.
- Neutropenia was the primary DLT; neurotoxicity was frequent but not dose-limiting.
Conclusions:
- Weekly cisplatin-paclitaxel is a safe, practical, and effective regimen for advanced solid neoplasms.
- G-CSF support allows for higher MTDs of both agents.
- Further Phase II trials are recommended to confirm efficacy in specific tumor types.