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'Tomudex' (raltitrexed) development: preclinical, phase I and II studies
1CRC Centre for Cancer Therapeutics, Belmont, Surrey, UK.
Anti-Cancer Drugs
|August 1, 1997
Summary
Raltitrexed offers a new treatment for advanced colorectal cancer with a simpler schedule and potentially less toxicity than current options. This novel drug shows promising response rates and survival benefits in clinical studies.
Area of Science:
- Oncology
- Pharmacology
Background:
- Advanced colorectal cancer treatment has lacked innovation for decades.
- Current therapies like 5-fluorouracil have complex schedules and significant toxicity.
- Raltitrexed represents a novel therapeutic approach for this unmet need.
Purpose of the Study:
- To evaluate the efficacy and safety of raltitrexed in patients with advanced colorectal cancer.
- To establish an optimal dosing schedule for raltitrexed.
- To explore the potential of raltitrexed in other solid tumors.
Main Methods:
- Phase I and pharmacokinetic studies to determine optimal dosing.
- Phase II study involving 177 patients with advanced colorectal cancer.
- Assessment of response rate, median survival, and adverse events.
Main Results:
- Optimal dose established at 3 mg/m2 intravenously every 3 weeks.
- Phase II study demonstrated a 26% response rate and 11.2 months median survival.
- Acceptable safety profile with manageable adverse events, primarily myelosuppression and gastrointestinal toxicity.
Conclusions:
- Raltitrexed is an active and well-tolerated drug for advanced colorectal cancer.
- Its targeted mechanism and convenient dosing offer advantages over existing treatments.
- Activity observed in other solid tumors warrants further investigation.