title: Phase II study of trabectedin in pretreated patients with advanced colorectal cancer.
abstract: OBJECTIVE
  This open-label, nonrandomized, phase II study was aimed at evaluating the efficacy and toxicity of trabectedin over a 3-hour intravenous infusion every 3 weeks in patients with pretreated advanced colorectal cancer.
  
  
  METHODS
  Twenty-one patients were enrolled: 5 patients (23.8%) were treated with 1650 microg/m(2), 10 patients (47.6%) with 1300 microg/m(2), and 6 patients (28.6%) with 1100 microg/m(2). Response to treatment was assessed according to World Health Organization criteria, and toxicities were graded according to National Cancer Institute Common Toxicity Criteria, version 2.0.
  
  
  RESULTS
  The median number of treatment cycles per patient was 2 (range, 1-6 cycles). No objective responses were reported. Four patients (19%; 95% confidence interval [CI], 5.5%-41.9%) exhibited stable disease lasting for a median of 3.6 months (range, 2.4-4.9 months). The median time to progression was 1.5 months (95% CI, 1.3-1.6 months), and the median overall survival was 4.4 months (95% CI, 3-7.5 months; n=2 censored). The main grade 3/4 toxicities were transient asymptomatic transaminase increase (alanine aminotransferase, 66.7% of patients; aspartate aminotransferase, 57.1%) and neutropenia (42.8%). No toxic deaths were reported.
  
  
  CONCLUSIONS
  Trabectedin 1300 microg/m(2) given as a 3-hour intravenous infusion every 3 weeks was well tolerated but lacked activity in pretreated advanced-stage colorectal cancer. Therefore, further clinical trials with this trabectedin schedule as a single agent are not warranted.
authors.affiliation: Medical Oncology Deparment, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Paz-Ares
authors.forename: Fernando
authors.initials: F
authors.lastname: Rivera-Herreros
authors.forename: Eduardo
authors.initials: E
authors.lastname: Díaz-Rubio
authors.forename: Margarita
authors.initials: M
authors.lastname: García
authors.forename: Esther
authors.initials: E
authors.lastname: Casado
authors.forename: Ricardo
authors.initials: R
authors.lastname: Cubedo
authors.forename: Cristina
authors.initials: C
authors.lastname: Gravalos
authors.forename: Vicente
authors.initials: V
authors.lastname: Alfaro
authors.forename: Javier
authors.initials: J
authors.lastname: Gómez
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Izquierdo
authors.forename: Josep
authors.initials: J
authors.lastname: Tabernero
mesh_terms: D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004149:Dioxoles / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D016879:Salvage Therapy; D015996:Survival Rate; D044005:Tetrahydroisoquinolines / Q000627:therapeutic use*; D013997:Time Factors; D000077606:Trabectedin
chemical_list: D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin