A phase I study of concurrent 9-nitro-20(s)-camptothecin (9NC/Orathecin) and radiation therapy in the treatment of locally advanced adenocarcinoma of the pancreas

Karen L. Tedesco, Jordan Berlin, Mace Rothenberg, Hak Choy, Ken Wyman, Adrian Scott Pearson, Robert Daniel Beauchamp, Nipun Merchant, A. Craig Lockhart, Yu Shyr, Carol Caillouette, Bapsi Chakravarthy

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Abstract

Background and purpose: In vitro studies have suggested that 9-nitro-20(s)-Camptothecin (9NC/Orathecin/Rubitecan) can enhance the effects of radiation. We conducted a phase I study to assess the toxicity and determine the maximum tolerated dose of 9NC when combined with radiation in patients with locally advanced adenocarcinoma of the pancreas. Patients and methods: Eleven patients with locally advanced adenocarcinoma of the pancreas received 9NC, orally during radiation. Radiation therapy consisted of 45 Gy in 25 fractions given over 5 weeks. The starting dose of 9NC was 1 mg/m2/day. Results: Eight patients received 9NC at a dose of 1 mg/m2/day and three patients received a dose of 1.25 mg/m2/day. Dose-limiting toxicity (DLT) was defined as ≥grade 3 non-hematologic toxicity and ≥grade 4 hematologic toxicity. Dose-limiting toxicity of grade 3 nausea/vomiting developed in one patient at the first dose level. At dose level 2, two of three patients developed DLT. Both developed grade 3 nausea, fatigue, and anorexia. Additionally, one of these patients had grade 3 dehydration and the other had grade 4 leukopenia, grade 3 vomiting, and grade 3 weakness. Conclusions: 9NC, 1 mg/m2/day, can be given concurrently with radiation with acceptable toxicity.

Original languageEnglish
Pages (from-to)54-58
Number of pages5
JournalRadiotherapy and Oncology
Volume76
Issue number1
DOIs
Publication statusPublished - 2005 Jul 1

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology
  • Radiology Nuclear Medicine and imaging

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    Tedesco, K. L., Berlin, J., Rothenberg, M., Choy, H., Wyman, K., Pearson, A. S., Beauchamp, R. D., Merchant, N., Lockhart, A. C., Shyr, Y., Caillouette, C., & Chakravarthy, B. (2005). A phase I study of concurrent 9-nitro-20(s)-camptothecin (9NC/Orathecin) and radiation therapy in the treatment of locally advanced adenocarcinoma of the pancreas. Radiotherapy and Oncology, 76(1), 54-58. https://doi.org/10.1016/j.radonc.2005.04.005