PHASE I STUDIES

Investigational New Drugs

, Volume 27, Issue 5, pp 453-460

First online:

Phase I trial of docetaxel given every 3 weeks and daily lenalidomide in patients with advanced solid tumors

  • Sharon L. SanbornAffiliated withDivision of Hematology and Oncology, MetroHealth Medical Center, Case Western Reserve University
  • , Joseph GibbonsAffiliated withDivision of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • , Smitha KrishnamurthiAffiliated withDivision of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • , Joanna M. BrellAffiliated withDivision of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • , Afshin DowlatiAffiliated withDivision of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • , Joseph A. BokarAffiliated withDivision of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • , Charles NockAffiliated withDivision of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • , Nancy HorvathAffiliated withDivision of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • , Jacob BakoAffiliated withDivision of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center
    • , Scot C. RemickAffiliated withMary Babb Randolph Cancer Center, West Virginia University
    • , Matthew M. CooneyAffiliated withDivision of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center Email author 

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Summary

Purpose Cytotoxic and anti-angiogenic drugs are efficacious in malignancies. This trial was undertaken to evaluate the toxicity of a novel regimen combining docetaxel and lenalidomide. Patients and methods Patients with advanced solid tumors were eligible. Docetaxel was administered on day 1, and lenalidomide was given on days 1–14 of each 21-day cycle. Since significant myelosuppression occurred, pegfilgrastim was added on day 2. Dose limiting toxicity (DLT) was defined as ≥grade 3 non-hematologic toxicity, grade 4 neutropenia with fever, or grade 4 anemia or thrombocytopenia. Results Thirty-three patients were enrolled. DLTs included neutropenia, nausea/vomiting, and dyspnea. Of the evaluable patients, 69% had stable disease, and 3% had partial response. Conclusions This regimen was well tolerated and provided stable disease in the majority of advanced cancer patients. The recommended phase II dosing is docetaxel 75 mg/m2 on day 1, lenalidomide 25 mg on days 1–14, and pegfilgrastim 6 mg on day 2, given every 3 weeks.

Keywords

Docetaxel Lenalidomide Phase I Anti-angiogenic