Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Berkeley, California 94704


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.


Study summary:

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.


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 (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


Study is Available At:


Original ID:

S0809


NCT ID:

NCT00789958


Secondary ID:

S0809


Study Acronym:


Brief Title:

S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct


Official Title:

A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

105


Enrollment Type:

Actual


Overall Contact Information

Official Name:Edgar Ben-Josef, MD
Principal Investigator
Barbara Ann Karmanos Cancer Institute

Study Dates

Start Date:December 2008
Completion Date:December 2017
Completion Type:Actual
Primary Completion Date:December 2014
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 12, 2018
First Received Date:November 12, 2008
First Results Date:August 2, 2016

Study Outcomes

Outcome Type:Secondary Outcome
Measure:2-year Overall Local Relapse Rate
Time Frame:Up to 2 years from registration
Safety Issues:False
Description:Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
Outcome Type:Secondary Outcome
Measure:2-year Stratum-specific Local Relapse Rate
Time Frame:Up to 2 years from registration
Safety Issues:False
Description:Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
Outcome Type:Secondary Outcome
Measure:2-year Disease-free Survival in All Patients
Time Frame:Up to 2 years from registration
Safety Issues:False
Description:Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome Type:Secondary Outcome
Measure:2-year Stratum-specific Disease-free Survival
Time Frame:Up to 2 years from registration
Safety Issues:False
Description:Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome Type:Secondary Outcome
Measure:2-year Overall Survival for All Patients
Time Frame:Up to 2 years from registration
Safety Issues:False
Description:Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome Type:Secondary Outcome
Measure:Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Time Frame:Up to 5 years
Safety Issues:False
Description:Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome Type:Primary Outcome
Measure:Stratum-specific (R0 and R1) 2-year Overall Survival
Time Frame:Up to 2 years from registration
Safety Issues:False
Description:Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Study Interventions

Intervention Type:Drug
Name:capecitabine
Description: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
Arm Name:Adjuvant Chemo+ Chemoradiotherapy
Other Name:Xeloda
Intervention Type:Drug
Name:gemcitabine hydrochloride
Description:1000 mg/m^2, IV, Days 1 & 8 of each cycle
Arm Name:Adjuvant Chemo+ Chemoradiotherapy
Other Name:Gemzar
Intervention Type:Radiation
Name:3-dimensional conformal radiation therapy
Description:4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.
Arm Name:Adjuvant Chemo+ Chemoradiotherapy
Other Name:3D radiotherapy
Intervention Type:Radiation
Name:intensity-modulated radiation therapy
Description: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.
Arm Name:Adjuvant Chemo+ Chemoradiotherapy
Other Name:IMRT

Study Arms

Study Arm Type:Experimental
Arm Name:Adjuvant Chemo+ Chemoradiotherapy
Description: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-mod

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.