S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Extrahepatic Bile Duct Cancer Gallbladder Cancer |
Drug: capecitabine Drug: gemcitabine hydrochloride Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC) |
- Stratum-specific (R0 vs R1) and overall 2-year survival (R0 stratum closed as of 12-15-11, R1 closed as of 10-1-12) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall and stratum-specific disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Survival by anatomic subsite [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Frequency and severity of toxicity as measured by CTCAE v4.0 [ Time Frame: Weeks 1 & 2 of each cycle, every 3 months until 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Adjuvant Chemo+ Chemoradiotherapy
Adjuvant Chemotherapy
Chemoradiotherapy -Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions. intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions. |
Drug: capecitabine
Adjuvant chemotherapy: 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle Chemoradiotherapy: 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT Other Names:
Drug: gemcitabine hydrochloride
1000 mg/m^2, IV, Days 1 & 8 of each cycle
Other Names:
Radiation: 3-dimensional conformal radiation therapy
4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.
Other Name: 3D radiotherapy
Radiation: intensity-modulated radiation therapy
4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
Other Name: IMRT
|
Detailed Description:
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. (R0 stratum closed as of 12-15-11)
- 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]). (R0 stratum closed as of 12-15-11)
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 (R0 stratum closed as of 12-15-11)
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
- No prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy for this disease
- No prior upper abdominal radiotherapy
Contacts and Locations
Show 251 Study Locations| Principal Investigator: | Edgar Ben-Josef, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00789958 History of Changes |
| Other Study ID Numbers: | CDR0000619334, S0809, U10CA032102 |
| Study First Received: | November 12, 2008 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
cholangiocarcinoma of the extrahepatic bile duct cholangiocarcinoma of the gallbladder localized extrahepatic bile duct cancer localized gallbladder cancer |
unresectable extrahepatic bile duct cancer unresectable gallbladder cancer metastatic extrahepatic bile duct cancer metastatic gallbladder cancer |
Additional relevant MeSH terms:
|
Cholangiocarcinoma Gallbladder Neoplasms Bile Duct Neoplasms Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Bile Duct Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Adjuvants, Immunologic Gemcitabine Capecitabine Fluorouracil Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013