NCT00033540

S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma

A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer

Interventions

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

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-04-01
• Completion: 2011-07-01
• First posted: 2003-01-27
• Last updated: 2017-09-12
• Results posted: 2012-08-28

Locations

112 sites across 1 country: United States