Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater
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|ClinicalTrials.gov Identifier: NCT00354887|
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : July 14, 2011
Last Update Posted : October 29, 2012
1. To determine the objective response rate (complete plus partial) to the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of the small bowel and ampulla of Vater.
Secondary objectives include determining the toxicity, time-to-treatment failure, and overall survival rates in patients treated with this combination.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancer||Drug: Capecitabine Drug: Oxaliplatin||Phase 2|
Oxaliplatin is a chemotherapy drug designed to destroy cancer cells by interfering with DNA function, which is necessary for growth of new cells.
Capecitabine is a chemotherapy drug designed to destroy cancer cells by interfering with cell division, which is important to the growth of cancer.
You will receive 14 days of treatment followed by 7 days without treatment, 21 days in all, otherwise known as a "cycle" of therapy. On Day 1 of each cycle, you will receive oxaliplatin injected into a vein over a period of 2 hours. For this injection, you will need to have a small tube inserted into a vein under the skin of the chest (central venous line) to receive oxaliplatin. Oxaliplatin must be given at M.D. Anderson.
You will take capecitabine tablets twice a day for the first two weeks (Days 1-14) of each 3-week cycle. No treatment will be given for the next 7 days. You must take capecitabine within 30 minutes after breakfast and dinner, with morning and evening doses about 12 hours apart. You should take capecitabine by mouth with water, and not 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.
During Cycle 1, routine blood tests (about 2 teaspoons of blood) will be done once a week. 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 by the study doctor about all medications you have taken since starting the study drugs and any health problems that you may have experienced. Also, you will have an x-ray or computed tomography (CT) scan of the chest and either CT scans or magnetic resonance imaging (MRIs) of the tumor(s) every 3 cycles 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.
This study will require you to receive at least 3 cycles of treatment. However, if you experience severe side effects or your disease becomes worse, 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 an 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 your state of health and ask you about further symptoms you may be experiencing.
This is an investigational study. The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum. The drugs are not approved for small bowel or ampulla of Vater cancer. Their use together in this study is investigational. Up to 30 people will take part in this study. All will be enrolled at M.D. Anderson.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Adenocarcinoma of the Small Bowel and Ampulla of Vater|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Experimental: Oxaliplatin + Capecitabine
Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
Oral capecitabine 750 mg/m^2 twice daily (total daily dose 1500 mg/m^2) on Days 1-14 in 21 Day Cycle.
Other Name: Xeloda
130 mg/m^2 by vein Day 1 over 2 hours in 21 Day Cycle
Other Name: Eloxatin
- Number of Participants With Overall Response [ Time Frame: Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses ]Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354887
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Robert A. Wolff, MD||M.D. Anderson Cancer Center|