At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma with locally advanced or metastatic disease that is unresectable
- ✓Measurable disease located outside prior radiotherapy port
- ✓Age 18 and over
- ✓Zubrod performance status 0-2
- ✕Carcinoid tumors or sarcomas
- ✕Severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil
- ✕Other malignancy within the past 5 years (except adequately treated skin cancer, cervical CIS, or stage I-II cancer in complete remission)
- ✕Clinically significant cardiac disease not well controlled by medication, congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias, or myocardial infarction within past 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
In Brief
A Phase 2 clinical trial evaluating capecitabine and gemcitabine hydrochloride for Extrahepatic Bile Duct Cancer and Gallbladder Cancer. Completed, enrolled 57 participants across 112 sites.
Detailed 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.
Study Details
Timeline
Interventions
650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days
1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days