Clinical trial NCT00338988
Conditions: Cancer of the Gallbladder Cancer of the Biliary Tract
Keywords: Gastrointestinal Capecitabine Oxaliplatin Carcinoma of the Gallbladder Carcinoma of the Intrahepatic or Extrahepatic Biliary Tract Xeloda Eloxatin
Sponsor: M.D. Anderson Cancer Center
Start date: 2003-08-01; Completion date: 2009-05-01
Enrollment: 44 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Participants may be either previously untreated or treated with chemotherapy. Participants will accrue to two strata based on pre-treatment status; separate response rates and statistical operating characteristics will be applied to each stratum.

The primary objective is to determine the objective response rate (complete plus partial) of XELOX in this population.

Secondary objectives include determining toxicity, stable disease rates, and median and overall survival of participants treated with this combination.

Detailed description:
Oxaliplatin causes death of cancer cells and other actively dividing cells by interfering with DNA function. Capecitabine causes death of cancer cells by interfering with certain molecules that are important in cell division.

After the screening portion of the study, if you are eligible to continue, you will begin treatment with oxaliplatin and capecitabine. Once treatment begins, you will come to M. D. Anderson at least every three weeks (21 days) for treatment. Each 21-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy unless side effects are severe or the cancer grows very quickly.

You will need to have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm to receive oxaliplatin. The central venous line will remain in place the entire time you are taking part in this study. Oxaliplatin must be given at M. D. Anderson. On Day 1 of each cycle, you will receive oxaliplatin injected into a vein over 2 hours.

You will take capecitabine tablets by mouth 2 times a day for the first 2 weeks (Days 1-14) of each 3-week cycle. No treatment will be given for the last 7 days of each cycle (except if your first dose of capecitabine for a new cycle is taken in the evening, your last dose will be taken in the morning of Day 15.) You must take capecitabine within 30 minutes after breakfast and dinner. The morning and evening doses should be about 12 hours apart. You should take capecitabine with water, and not with fruit juices. At the first treatment visit and every 3 weeks, you will receive enough capecitabine to last until the next visit. At each visit, you must return any capecitabine you have not used as well as all empty bottles.

Before each new cycle of therapy, you will have a complete physical exam and blood (about 2 ½ teaspoons) will be collected for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. During the first cycle, you will have a blood (about 2 teaspoons) sample collected each week for routine tests. You will also have either CT scans or a MRI of the tumor(s) every 9 weeks and at the end of the study. Additional tests may be done during the study if your doctor feels it is necessary for your care.

If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.

When you stop taking part in the study, you will have blood (about 3 teaspoons) collected for routine tests. You will have a physical exam and either a CT scan or a MRI to check on the status of the disease. You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing.

All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson.

This is an investigational study. The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum. However, the drugs are not approved for gallbladder or biliary tract cancer. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Combination of intravenous (IV) oxaliplatin 100 mg/m\^2 Day 1 and oral (PO) capecitabine 750 mg/m\^2 twice daily (total daily dose 1500 mg/m2) on Days 1-14.
Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: 1500 mg/m\^2 PO twice daily x 14 days. intervention 2: 130 mg/m\^2 IV over 2 hours on day 1 of cycle.

Protocol documents: