title: The combination of capecitabine and thalidomide in previously treated, refractory metastatic colorectal cancer.
abstract: BACKGROUND
  With the increasing survival of patients with metastatic colorectal cancer (CRC) there is a growing need for effective second- and third-line agents. We conducted a multicenter, phase II study to examine the combination of capecitabine and thalidomide (Cape/Thal) in patients with refractory metastatic CRC.
  
  
  METHODS
  Patients with previously treated stage IV CRC were eligible. Treatment consisted of capecitabine at 1,000 mg/m2 po BID for 14 days every 3 weeks and thalidomide, starting at 200 mg po QD continuously. Thalidomide was escalated individually to 600 mg po QD as tolerated. We analyzed overall survival (OS), progression-free survival, response, and toxicity rates.
  
  
  RESULTS
  Thirty-four eligible patients were enrolled. The median age was 57 years, and most patients had a normal performance status (65%). All patients had received prior chemotherapy and 19 (56%) had received 2 or 3 prior regimens. The median number of Cape/Thal cycles administered was 3 (range, 1-15). Grade 3/4 toxicities included fatigue (15%), venous thromboembolic events (12%), somnolence (12%), and constipation (9%). Grade 2 hand-foot syndrome occurred in 5 (15%) patients. There were no radiographic responses; 13 patients (38%) achieved stable disease. The median PFS was 2.6 months (95% confidence interval [CI] = 2.2-3.9) and the median OS was 7.1 month (95% CI = 5.2-12.0).
  
  
  CONCLUSIONS
  Though well-tolerated, the combination of capecitabine and thalidomide was not associated with objective tumor responses in a population of patients with previously treated metastatic CRC.
authors.affiliation: Texas Oncology, PA, and Baylor-Sammons Cancer Center, Dallas, TX 75246, USA. david.mccollum@usoncology.com
authors.forename: A David
authors.initials: AD
authors.lastname: McCollum
authors.forename: Bingyan
authors.initials: B
authors.lastname: Wu
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Clark
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Kulke
authors.forename: Peter C
authors.initials: PC
authors.lastname: Enzinger
authors.forename: David P
authors.initials: DP
authors.lastname: Ryan
authors.forename: Craig C
authors.initials: CC
authors.lastname: Earle
authors.forename: Ann
authors.initials: A
authors.lastname: Michelini
authors.forename: Charles S
authors.initials: CS
authors.lastname: Fuchs
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D003841:Deoxycytidine; D013792:Thalidomide; D000069287:Capecitabine; D005472:Fluorouracil