A Phase 3 interventional study of cisplatin and gemcitabine hydrochloride in Extrahepatic Bile Duct Cancer and Gallbladder Cancer, sponsored by University College, London. Completed at 25 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2012-07-17.
Sponsored by University College, London · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors.
PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.
OBJECTIVES:
Primary
Secondary
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.
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's enrollment of 324 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Glomerular filtration rate (GFR) ≥ 45 mL/min
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
Other
Prior photodynamic therapy (PDT) allowed provided it was given for localized disease only (with no evidence of metastatic disease) and resulted in subsequent disease progression after completion of therapy OR to relieve biliary obstruction in the presence of metastatic disease
Gemcitabine alone
Drug: gemcitabine hydrochloride
Gemcitabine and Cisplatin
Drug: cisplatin · Drug: gemcitabine hydrochloride
25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins
Also known as: CDDP, cis-diamminedichloroplatinum(II), cisplatinum
1000mg/m2 in 250-500mls 0.9% saline over 30 mins by intravenous infusions on day 1, 8 and 15 (Arm A only) of each 28 (Arm A) or 21 (Arm B) day cycle.
Also known as: Gemzar
Overall Survival
From date of randomisation till date of death or last date of follow-up (up to 5 years)
Time frame: From date of randomisation till date of death or last date of follow-up (up to 5 years)
Progression-free survival
From date of randomisation till date of death or last date of follow-up (up to 5 years)
Time frame: From date of randomisation till date of death or last date of follow-up (up to 5 years)
Quality of life
Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically
Time frame: Before and 12 weeks after completion of treatment
Toxicity
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.
Time frame: During treatment and follow-up
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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University College, London