Phase I study of weekly (day 1 and 8) docetaxel in combination with capecitabine in patients with advanced solid malignancies

Ramesh K. Ramanathan, Sakkaraiappan Ramalingam, Merrill J. Egorin, Chandra P. Belani, Douglas M. Potter, Marwan Fakih, Laura L. Jung, Sandra Strychor, Samuel A. Jacobs, David M. Friedland, Dong M. Shin, Gurkamal S. Chatta, Susan Tutchko, William C. Zamboni

Research output: Contribution to journalArticlepeer-review

15 Scopus citations


Purpose: Capecitabine in combination with docetaxel given every 3 weeks has shown a high degree of activity in a number of tumor types, but at the expense of significant toxicity. To improve the therapeutic index, we evaluated a weekly regimen of docetaxel in combination with capecitabine, and determined the maximum tolerated dose, toxicities and pharmacokinetics of this combination. Patients and methods: Patients with advanced solid malignancies were treated with docetaxel on days 1 and 8, and capecitabine, twice daily on days 1-14, of an every-21-day cycle. Pharmacokinetics of docetaxel were assessed on days 1 and 8 of the first cycle of chemotherapy. Results: Enrolled in the study were 25 patients. The most frequent toxicities were asthenia, hand-foot syndrome and mucositis. Inability to deliver at least 75% of the planned doses of both drugs during the first two cycles of chemotherapy was noted at dose levels 2, 3 and 4. Dose level 1 (docetaxel 30 mg/m2 and capecitabine 825 mg/m 2 twice daily) is the recommended dose for phase II studies. Five patients experienced a partial response, and eight patients had stabilization of disease. Coadministration of capecitabine did not alter the pharmacokinetics of docetaxel. Conclusion: The regimen consisting of docetaxel 30 mg/m2 (days 1, 8) and capecitabine 825 mg/m2 twice daily (days 1-14) was well tolerated. Capecitabine did not alter pharmacokinetics of docetaxel. Further testing of this regimen in tumor-specific trials, especially gastric, lung and breast cancer, is warranted.

Original languageEnglish (US)
Pages (from-to)354-360
Number of pages7
JournalCancer chemotherapy and pharmacology
Issue number4
StatePublished - Apr 2005


  • Capecitabine
  • Combination
  • Docetaxel
  • Pharmacokinetics
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)


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