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PCNU: phase II evaluation in advanced colorectal carcinoma
R Pazdur1, M K Samson, L H Baker
1Department of Internal Medicine, Wayne State University, Harper-Grace Hospitals, Detroit, MI 48201.
Investigational New Drugs
|June 1, 1988
Summary
N-(2-chloroethyl)-N-nitrosourea (PCNU) showed limited efficacy in patients with metastatic colorectal cancer. The chemotherapy demonstrated significant hematological toxicity, including life-threatening leukopenia and thrombocytopenia, with minimal therapeutic benefit.
Area of Science:
- Oncology
- Pharmacology
Background:
- Metastatic adenocarcinoma of the colon and rectum presents a significant therapeutic challenge.
- Previously treated patients often have limited options for effective systemic therapy.
Purpose of the Study:
- To evaluate the efficacy and toxicity of N-(2-chloroethyl)-N-nitrosourea (PCNU) in patients with metastatic colorectal cancer.
- To assess the safety profile of PCNU in this patient population.
Main Methods:
- A total of 37 previously treated patients with metastatic colorectal cancer received PCNU.
- PCNU was administered intravenously at doses of 100 mg/m2 (good risk) or 75 mg/m2 (poor risk) every 6 weeks.
- Poor risk criteria included age over 65 or liver enzymes > 2x normal.
Main Results:
- No complete responses were observed in the study population.
- One patient (treated with 100 mg/m2) achieved a partial response.
- Significant hematological toxicity was noted, with six patients experiencing life-threatening leukopenia and thrombocytopenia.
Conclusions:
- PCNU demonstrated minimal therapeutic efficacy in previously treated patients with metastatic colorectal cancer.
- The observed hematological toxicities suggest a poor risk-benefit ratio for PCNU in this setting.
- Further investigation into PCNU for metastatic colorectal cancer is not warranted based on these findings.