Capecitabine, Gemcitabine, and Radiation Therapy in Treating Patients With Cholangiocarcinoma of the Gallbladder or Bile Duct - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00789958

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 Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy	Phase II

Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Capecitabine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Stratum-specific (R0 vs R1) and overall 2-year survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall and stratum-specific disease-free survival [ Designated as safety issue: No ]
Survival by anatomic subsite [ Designated as safety issue: No ]
Frequency and severity of toxicity as measured by CTCAE v4.0 [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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.
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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789958

Show 261 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Edgar Ben-Josef, MD

Barbara Ann Karmanos Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00789958 History of Changes
Other Study ID Numbers:	CDR0000619334, SWOG-S0809
Study First Received:	November 12, 2008
Last Updated:	April 7, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Gallbladder Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
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 February 09, 2012