Overview

This trial is active, not recruiting.

Conditions extrahepatic bile duct cancer, gallbladder cancer
Treatments capecitabine, gemcitabine hydrochloride, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy
Phase phase 2
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date December 2008
End date December 2014
Trial size 80 participants
Trial identifier NCT00789958, NCI-2009-00801, S0809, U10CA032102

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Adjuvant Chemotherapy Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle 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.
capecitabine Xeloda
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
gemcitabine hydrochloride Gemzar
1000 mg/m^2, IV, Days 1 & 8 of each cycle
3-dimensional conformal radiation therapy 3D radiotherapy
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 IMRT
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Overall and stratum-specific disease-free survival
time frame: 2 years
Survival by anatomic subsite
time frame: 2 years
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

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
Principal investigator Edgar Ben-Josef, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.