Capecitabine, Gemcitabine, and Radiation Therapy in Treating Patients With Cholangiocarcinoma of the Gallbladder or Bile Duct - NCT00789958-45267 (Clinical Trial 252690)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy252690.aspx
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| City: |
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Cincinnati |
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State:
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OH |
| Zip Code: |
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45267 |
| Conditions: |
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Extrahepatic Bile Duct Cancer - Gallbladder Cancer |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
Specialized radiation therapy that delivers a high dose of radiation directly to the tumor
may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug
(combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with
gemcitabine followed by capecitabine and radiation therapy works in treating patients with
cholangiocarcinoma of the gallbladder or bile duct.
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| Study summary: |
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OBJECTIVES:
- To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities
of patients with extrahepatic cholangiocarcinoma treated with adjuvant chemotherapy
comprising capecitabine and gemcitabine hydrochloride, followed by capecitabine and
radiotherapy.
- To estimate the 2-year stratum-specific and overall disease-free survival and local
disease-free survival of patients treated with this regimen.
- To assess the frequency and severity of toxicity in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to margin of
resection (negative [R0] vs microscopically positive [R1]).
- Adjuvant chemotherapy: Patients receive oral capecitabine every 12 hours on days 1-14
and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats
every 21 days for 4 courses in the absence of disease progression or unacceptable
toxicity.
- Chemoradiotherapy: Beginning in week 13, patients receive oral capecitabine every 12
hours on days 1-7. Patients also undergo concurrent three-dimensional or
intensity-modulated radiotherapy on days 1-5. Treatment repeats weekly for 5-6 weeks in
the absence of disease progression or unacceptable toxicity.
After completion of study therapy patients are followed periodically for up to 5 years. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or
bile duct, meeting at least 1 of the following criteria:
- Pathological T2-4 disease
- Pathological N1 disease
- Positive margins (any T or N )
- Must have undergone potentially curative radical resection with negative (R0) or
microscopically positive (R1) margins within the past 56 days and recovered
- No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen,
and pelvis within the past 42 days
- Positive resected regional lymph nodes allowed
- No ampullary cancer
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC > 1,500/μL
- Platelet count > 100,000/μL
- Serum creatinine < 1.5 mg/dL
- Total bilirubin < 1.5 times upper limit of normal (ULN)
- SGOT or SGPT < 2.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to swallow enteral medications and no requirement for a feeding tube
- No intractable nausea or vomiting
- No gastrointestinal (GI) tract disease resulting in an inability to take oral
medication, malabsorption syndrome, requirement for IV alimentation, prior surgical
procedures affecting absorptions. or uncontrolled inflammatory GI disease (e.g.,
Crohn disease, ulcerative colitis)
- No uncontrolled intercurrent illness including but not limited to any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Myocardial infarction or cerebrovascular accident within the past 3 months
- Uncontrolled diarrhea
- Psychiatric illness or social situations that would limit compliance with study
requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy for this disease
- No prior upper abdominal radiotherapy |
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| Study is available at: |
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Charles M. Barrett Cancer Center at University Hospital
Cincinnati, OH 45267
United States
Primary Contact:
Leslie Oleksowicz
Phone: 513-584-3200 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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