Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors (ABC-02)

• Overall Survival [ Time Frame: From date of randomisation till date of death or last date of follow-up (up to 5 years) ] [ Designated as safety issue: No ]
  From date of randomisation till date of death or last date of follow-up (up to 5 years)
  
  

• Progression-free survival [ Time Frame: From date of randomisation till date of death or last date of follow-up (up to 5 years) ] [ Designated as safety issue: No ]
  From date of randomisation till date of death or last date of follow-up (up to 5 years)
  
  
• Quality of life [ Time Frame: Before and 12 weeks after completion of treatment ] [ Designated as safety issue: No ]
  Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically
  
  
• Toxicity [ Time Frame: During treatment and follow-up ] [ Designated as safety issue: Yes ]
  Toxicity as measured by NCI CTC periodically. The proportion of patients who experience a toxicity of grade 3 or 4 will be compared between the two arms of the trial.
  
  

OBJECTIVES:

Primary

• Compare the overall survival of patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine hydrochloride with vs without cisplatin.

Secondary

• Compare the progression-free survival of patients treated with these regimens.
• Compare the toxic effects of these regimens in these patients.
• Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary site of disease (gallbladder vs bile ducts vs ampulla), prior therapy (photodynamic therapy [PDT] vs non-PDT therapy vs none), ECOG performance status (0 vs 1 vs 2), and disease status (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1½ hours on days 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 12 weeks, and after finishing treatment.

After completion of study treatment, patients are followed periodically for at least 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.