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[Phase I clinical study of oxaliplatin]
T Taguchi1, S Tsukagoshi, H Furue
1Japan Society for Cancer Chemotherapy, School of Medicine, Teikyo University.
Gan to Kagaku Ryoho. Cancer & Chemotherapy
|November 3, 1998
Summary
This study evaluated Oxaliplatin, a new platinum derivative, in 20 cancer patients. The recommended dose for further trials is 130 mg/m2, with peripheral sensory neuropathy as the main side effect.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Oxaliplatin is a novel platinum-based chemotherapy agent.
- Platinum derivatives are crucial in cancer treatment.
Purpose of the Study:
- To determine the safety and recommended dosage of Oxaliplatin as a monotherapy.
- To evaluate the pharmacokinetic profile of Oxaliplatin.
Main Methods:
- A multicentric Phase I clinical trial involving 20 patients with various advanced cancers.
- Oxaliplatin was administered intravenously at escalating doses (20-180 mg/m2) every 3 weeks.
- Plasma platinum concentrations and toxicity were monitored.
Main Results:
- Dose-limiting toxicity was reversible peripheral sensory neuropathy.
- Minimal hematotoxicity and no nephrotoxicity were observed.
- Oxaliplatin exhibited dose-dependent pharmacokinetics with a T1/2 beta of 31.3 hours.
Conclusions:
- The recommended dose for further studies is 130 mg/m2.
- Oxaliplatin shows a manageable safety profile and promising activity, including a partial response in endometrial cancer.