Phase II trial of carboplatin and infusional cyclosporine with alpha-interferon in recurrent ovarian cancer: A California Cancer Consortium Trial

R. J. Morgan, T. W. Synold, David R Gandara, F. Muggia, Sidney A Scudder, E. Reed, K. Margolin, J. Raschko, L. Leong, S. Shibata, M. Tetef, S. Vasilev, K. McGonigle, J. Longmate, Y. Yen, W. Chow, G. Somlo, M. Carroll, J. H. Doroshow

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)373-378
Number of pages6
JournalInternational Journal of Gynecological Cancer
Volume17
Issue number2
DOIs
StatePublished - Mar 2007

Keywords

  • Chemomodulation
  • Chemotherapy
  • Phase II

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology
  • Cancer Research

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