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Phase II trial of carboplatin and infusional cyclosporine with alpha-interferon in recurrent ovarian cancer: a California Cancer Consortium Trial
  1. R. J. Morgan*,
  2. T. W. Synold*,
  3. D. Gandara,
  4. F. Muggia,
  5. S. Scudder,
  6. E. Reed§,
  7. K. Margolin*,
  8. J. Raschko*,
  9. L. Leong*,
  10. S. Shibata*,
  11. M. Tetef*,
  12. S. Vasilev,
  13. K. Mcgonigle,
  14. J. Longmate,
  15. Y. Yen*,
  16. W. Chow*,
  17. G. Somlo*,
  18. M. Carroll* and
  19. J. H. Doroshow*
  1. * Division of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, California
  2. Department of Medical Oncology, University of California, Davis, Davis, California
  3. Department of Medical Oncology, University of Southern California, Los Angeles, California
  4. § Medicine Branch, National Cancer Institute, Bethesda, Maryland
  5. Department of Gynecologic Oncology
  6. Department of Biostatistics, City of Hope National Medical Center, Duarte, California
  1. Address correspondence and reprint requests to: Robert J. Morgan, Jr, MD, Division of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, 1500 E Duarte Road, Duarte, CA 91010, USA. Email: rmorgan{at}


The purpose of this study was to estimate the response rate of 26-h continuous infusion cyclosporine A (CSA) combined with carboplatin (CBDCA) and subcutaneous alpha-interferon (IFN), in recurrent ovarian cancer (OC), and to measure their effects on CBDCA pharmacokinetics. OC patients relapsing following platinum-based chemotherapy received CBDCA area under the curve (AUC 3) with CSA and IFN, every 3 weeks. The pharmacokinetics of CSA and CBDCA were determined in a subset of patients. Thirty patients received 84 courses of therapy. Three partial responses were observed. Nine patients were stable for >4 months. Toxicity was similar to that observed in our previously reported phase I study and consisted of myelosuppression, nausea, vomiting, and headache. The mean end of infusion CSA level (high-performance liquid chromatographic assay [HPLC]) was 1109 ± 291 μg/mL (mean ± SD). CBDCA pharmacokinetics revealed a measured AUC of 3.61 versus a targeted AUC of 3, suggesting a possible effect of IFN on CBDCA levels versus errors in the estimation of CBDCA clearance using measured creatinine clearance. Steady-state levels of >1 μg/mL CSA (HPLC assay) are achievable in vivo. Insufficient clinical resistance reversal was observed in this study to warrant further investigation of this combination.

  • chemomodulation
  • chemotherapy
  • phase II

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