Conditions: Extrahepatic Bile Duct Cancer Gallbladder Cancer
Keywords: unresectable gallbladder cancer recurrent gallbladder cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer adenocarcinoma of the gallbladder adenocarcinoma with squamous metaplasia of the gallbladder squamous cell carcinoma of the gallbladder adenocarcinoma of the extrahepatic bile duct cholangiocarcinoma of the gallbladder cholangiocarcinoma of the extrahepatic bile duct
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 57
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have locally advanced or metastatic gallbladder cancer or cholangiocarcinoma.

Detailed description:
OBJECTIVES:

* Determine the response rates (confirmed complete and partial responses) in patients with unresectable, locally advanced or metastatic gallbladder cancer or cholangiocarcinoma treated with gemcitabine and capecitabine.
* Determine the overall survival of patients treated with this regimen.
* Determine the quantitative and qualitative toxic effects of this regimen in these patients.
* Determine the feasibility of accruing patients with these disease sites.
* Evaluate, preliminarily, relevant prognostic markers in these disease sites and the prognostic implications as predictors of survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14 and gemcitabine IV over 100 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within approximately 10-20 months.

Arms:
arm 1: Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days

Interventions: intervention 1: capecitabine intervention 2: gemcitabine hydrochloride
Intervention descriptions: intervention 1: 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days intervention 2: 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days

Protocol document: