Literature DB >> 19011760

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

Sharon L Sanborn1, Joseph Gibbons, Smitha Krishnamurthi, Joanna M Brell, Afshin Dowlati, Joseph A Bokar, Charles Nock, Nancy Horvath, Jacob Bako, Scot C Remick, Matthew M Cooney.   

Abstract

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 >or=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/m(2) on day 1, lenalidomide 25 mg on days 1-14, and pegfilgrastim 6 mg on day 2, given every 3 weeks.

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Year:  2008        PMID: 19011760     DOI: 10.1007/s10637-008-9200-x

Source DB:  PubMed          Journal:  Invest New Drugs        ISSN: 0167-6997            Impact factor:   3.850


  48 in total

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