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


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.
Sanborn
Sharon L
SL
Division of Hematology and Oncology, MetroHealth Medical Center, Case Western Reserve University, 2500 MetroHealth Drive, Cancer Care Center, Cleveland, OH 44109, USA.
Gibbons
Joseph
J
Krishnamurthi
Smitha
S
Brell
Joanna M
JM
Dowlati
Afshin
A
Bokar
Joseph A
JA
Nock
Charles
C
Horvath
Nancy
N
Bako
Jacob
J
Remick
Scot C
SC
Cooney
Matthew M
MM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D011379:Prognosis; D043823:Taxoids / Q000008:administration & dosage; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome; D055815:Young Adult
D043823:Taxoids; D000077143:Docetaxel; D013792:Thalidomide; D000077269:Lenalidomide