title: Phase II study of carboxyamidotriazole in patients with advanced renal cell carcinoma refractory to immunotherapy: E4896, an Eastern Cooperative Oncology Group Study.
abstract: BACKGROUND
  The current study evaluated the response rate and 6-month time to disease progression of the antiangiogenesis agent carboxyamidotriazole (CAI) in patients with metastatic renal cell carcinoma (RCC).
  
  
  METHODS
  Fifty-seven patients with histologically confirmed metastatic RCC that progressed after biologic therapy (interferon or interleukin-2) were enrolled. Four patients were ineligible. CAI was administered orally as a 28-day cycle. Response and time to disease progression were evaluated.
  
  
  RESULTS
  Fifteen of 53 eligible patients received > 5 cycles, but 13 patients eventually discontinued treatment because of progressive disease. The majority of toxicities were Grade 1. However, Grade 3/4 toxicities did occur, the majority of which were gastrointestinal in nature. One of 47 patients evaluable achieved a partial response (1.9%) lasting 172 days. Six of 53 patients were alive and disease progression free at 6 months from the start of treatment (11.3%). The median overall survival was 12.5 months. The survival periods in the low-risk, intermediate-risk, and poor-risk groups were 16.2 months, 20.9 months, and 5.8 months, respectively.
  
  
  CONCLUSIONS
  Patients in trials of second-line therapy appear to have a better prognosis than previously considered, in part because they are eligible for another clinical trial. CAI was found to have little to no effect on the natural history of progressive RCC.
authors.affiliation: Our Lady of Mercy Cancer Center/New York Medical College, Bronx, New York 10466, USA. jpd4401@aol.com
authors.forename: Janice P
authors.initials: JP
authors.lastname: Dutcher
authors.forename: Larry
authors.initials: L
authors.lastname: Leon
authors.forename: Judith
authors.initials: J
authors.lastname: Manola
authors.forename: David M
authors.initials: DM
authors.lastname: Friedland
authors.forename: Bruce
authors.initials: B
authors.lastname: Roth
authors.forename: George
authors.initials: G
authors.lastname: Wilding
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D013997:Time Factors; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use* / Q000633:toxicity*
chemical_list: D000970:Antineoplastic Agents; D014230:Triazoles; C062058:carboxyamido-triazole