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RFS2000 (9-nitrocamptothecin) in advanced small cell lung cancer, a phase II study of the EORTC New Drug Development
C J A Punt1, M J A de Jonge, S Monfardini
1Department of Medical Oncology, University Medical Center St. Radboud, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands. c.punt@onco.umcn.nl
Abstract:
Camptothecins have shown efficacy in terms of response rate in patients with small cell lung cancer (SCLC). RFS2000 is a new camptothecin derivative, which has shown objective responses in various tumour types. The aim of this phase II study was to determine the objective response rate of RFS2000 in patients with sensitive and refractory SCLC. RFS2000 was given orally at 1.5 mg/m(2) per day for five consecutive days (five days on - two days off) on a continuous basis. Patients were evaluated weekly for toxicity and every six weeks for response. Thirty seven patients were included, 36 patients (14 with sensitive and 22 with refractory SCLC) were evaluable for toxicity, and 35 patients were evaluable for response. No objective responses were observed. Toxicity was acceptable, with myelosuppression, nausea/vomiting, and diarrhoea as the main toxicities. RFS2000 therefore has an acceptable toxicity profile but is not active as a single agent in SCLC.
Insights
This phase II study found that RFS2000, a novel camptothecin derivative, showed no objective responses in patients with small cell lung cancer (SCLC). While RFS2000 demonstrated an acceptable toxicity profile, it was not active as a single agent.
Area of Science:
- Oncology
- Pharmacology
Background:
- Camptothecins demonstrate efficacy in treating small cell lung cancer (SCLC).
- RFS2000, a novel camptothecin derivative, has shown objective responses in various tumor types.
Purpose of the Study:
- To determine the objective response rate of RFS2000 in patients with sensitive and refractory SCLC.
- To evaluate the safety and efficacy of RFS2000 as a single agent in SCLC treatment.
Main Methods:
- A phase II clinical trial was conducted.
- Oral RFS2000 was administered at 1.5 mg/m(2)/day for five consecutive days (five days on - two days off) on a continuous basis.
- Patients were monitored weekly for toxicity and every six weeks for response.
Main Results:
- Thirty-seven patients were enrolled; 35 were evaluable for response.
- No objective responses were observed in either sensitive or refractory SCLC patients.
- The main toxicities included myelosuppression, nausea/vomiting, and diarrhea, which were deemed acceptable.
Conclusions:
- RFS2000 exhibits an acceptable toxicity profile in SCLC patients.
- RFS2000 is not active as a single agent for treating small cell lung cancer.
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