Trial record 3 of 8 for:    cholangiocarcinoma | United States, North Carolina

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00789958
First received: November 12, 2008
Last updated: January 13, 2014
Last verified: January 2014
  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)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

  • 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.

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:
  • Xeloda
  • NSC-712807
Drug: gemcitabine hydrochloride
1000 mg/m^2, IV, Days 1 & 8 of each cycle
Other Names:
  • Gemzar
  • NSC-619927
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 251 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
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 13, 2014
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
Gemcitabine
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014