Phase II trial of CPT-11 in patients with advanced pancreatic cancer, an EORTC early clinical trials group study

• Published in: Annals of oncology 1995-02, Vol.6 (2), p.129-132
• Main Authors: Wagener, D. J. Th, Verdonk, H. E. R., Dirix, L. Y., Catimel, G., Siegenthaler, P., Buitenhuis, M., Mathieu-Boué, A., Verweij, J.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic agents; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Agents, Phytogenic - adverse effects; Antineoplastic Agents, Phytogenic - therapeutic use; Biological and medical sciences; Bone Marrow Diseases - chemically induced; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Camptothecin - therapeutic use; Chemotherapy; CPT-11; Disease-Free Survival; Female; Gastrointestinal Diseases - chemically induced; Humans; Infusions, Intravenous; Irinotecan; Male; Medical sciences; Middle Aged; pancreatic cancer; Pancreatic Neoplasms - drug therapy; Pancreatic Neoplasms - mortality; Pancreatic Neoplasms - pathology; Pharmacology. Drug treatments; Remission Induction; Topoisomerase I Inhibitors; Treatment Outcome
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/oxfordjournals.annonc.a059107

Background CPT-11 (irinotecan) is a semi-synthetic derivative of camptothecin and exerts its activity by inhibiting DNA topoisomerase I. A phase II study of this drug was performed in patients with pancreatic cancer. Patients and methods Eligibility criteria included advanced non-chemotherapy-pretreated pancreatic cancer. CPT-11 was administered as a 30-minute i.v. infusion at a dose of 350 mg/m2 diluted in 250 ml normal saline every 3 weeks. Results Thirty-four eligible patients were enrolled in the study, thirty-two of them were evaluated, and three achieved partial responses (9%; 95% C.I. = 3%–25%). The duration of response was 7.2, 7.5 and 7.8 months, respectively. Thirteen patients had no change, fourteen patients had progressive disease and two had early progressive disease. The median duration of survival for all patients treated was 5.2 months. The main toxicities (CTC grade>3) were diarrhea, leuko-cytopenia, asthenia, nausea and vomiting in, respectively, 7%, 16%, 8%, 6%, 4% of the courses. Thse toxicities were reversible and manageable with anti-emetics and prophylactic or curative antidiarrheal agents. Conclusion CPT-11 is an interesting moderately effective drug in pancreatic cancer.