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Adjuvant Palliative Capecitabine and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Biliary Tract Cancer

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
capecitabine plus gemcitabine
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Extrahepatic Bile Duct Cancer focused on measuring unresectable gallbladder cancer, adenocarcinoma of the gallbladder, adenocarcinoma of the extrahepatic bile duct, unresectable extrahepatic bile duct cancer, pain, recurrent gallbladder cancer, recurrent extrahepatic bile duct cancer, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed biliary tract cancer Locally advanced, unresectable, or metastatic disease Metastatic adenocarcinoma with clinical documentation of gallbladder or bile tree involvement with no evidence of another primary adenocarcinoma allowed Measurable or nonmeasurable disease Treatable biliary duct obstruction must be relieved by either internal endoscopic drainage/stenting or palliative bypass surgery before study entry Symptomatic biliary tract cancer and has at least 1 of the following: Karnofsky 60-80% Baseline analgesic consumption at least 10 mg of morphine equivalents per day Baseline pain intensity score of at least 20 mm out of a possible 100 mm No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: Age 18 to 80 Performance status See Disease Characteristics Karnofsky 60-100% Life expectancy Not specified Hematopoietic Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL Hepatic Bilirubin no greater than 4 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN AST and ALT no greater than 5 times ULN Renal Creatinine clearance greater than 50 mL/min Cardiovascular No uncontrolled cardiovascular disease Gastrointestinal Able to ingest oral medication No malabsorption syndrome No intractable nausea and/or vomiting No partial small bowel obstruction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study participation No active autoimmune disease No uncontrolled diabetes No known hypersensitivity to fluorouracil No known dihydropyrimidine dehydrogenase deficiency No definitive contraindication to corticosteroids No prior significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) that would preclude understanding or providing informed consent No prior severe reaction to fluoropyrimidine therapy No psychiatric disorder, cognitive dysfunction, or language problem that would preclude filling out the quality of life questionnaire or patient diary No other serious underlying medical condition that would preclude study participation No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy No prior immunotherapy Chemotherapy No prior chemotherapy for advanced/metastatic disease No prior palliative chemotherapy Endocrine therapy No concurrent megestrol Radiotherapy More than 4 weeks since prior radiotherapy No concurrent radiotherapy Treatment of a single painful lesion allowed Surgery See Disease Characteristics Prior Whipple procedure allowed Prior duodenal bypass allowed No concurrent endoscopic or external biliary drainage as a consequence of progressive malignant bile duct obstruction Drainage as a consequence of nonmalignant bile duct obstruction allowed Other More than 30 days since prior treatment within a clinical study No other concurrent anticancer drugs No other concurrent investigational drugs No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)

Sites / Locations

  • Kantonsspital - St. Gallen

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Arm A

Arm Description

Capecitabine plus Gemcitabine

Outcomes

Primary Outcome Measures

Ability of palliative capecitabine and gemcitabine
Determine the ability of palliative capecitabine and gemcitabine to maintain or improve tumor-related symptoms (after treatable biliary duct obstruction has been relieved) as measured by the clinical benefit response.

Secondary Outcome Measures

Clinical benefit response alone as measured after 3 courses

Full Information

First Posted
December 10, 2003
Last Updated
June 2, 2012
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00073905
Brief Title
Adjuvant Palliative Capecitabine and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Official Title
Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Palliative chemotherapy may improve the quality of life in patients who have locally advanced or metastatic biliary tract cancer and may help them live more comfortably. PURPOSE: Phase II trial to study the effectiveness of adjuvant capecitabine and gemcitabine in improving quality of life in patients who have locally advanced or metastatic biliary tract cancer.
Detailed Description
OBJECTIVES: Primary Determine the ability of palliative capecitabine and gemcitabine to maintain or improve tumor-related symptoms (after treatable biliary duct obstruction has been relieved) as measured by the clinical benefit response in patients with locally advanced or metastatic biliary tract cancer. Secondary Determine the clinical benefit response in patients treated with this regimen. Determine the time to and duration of clinical benefit response in patients treated with this regimen. Determine the objective response and time to progression in patients treated with this regimen. Determine the overall survival of patients treated with this regimen. Determine the quality of life of patients treated with this regimen. Determine the adverse events in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 (28 total doses). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive additional courses at the discretion of the investigator. Quality of life is assessed at baseline, weekly during weeks 2-9 (courses 1-3), and then before each administration of gemcitabine. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 19-44 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer, Pain
Keywords
unresectable gallbladder cancer, adenocarcinoma of the gallbladder, adenocarcinoma of the extrahepatic bile duct, unresectable extrahepatic bile duct cancer, pain, recurrent gallbladder cancer, recurrent extrahepatic bile duct cancer, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Capecitabine plus Gemcitabine
Intervention Type
Drug
Intervention Name(s)
capecitabine plus gemcitabine
Intervention Description
capecitabine plus gemcitabine
Primary Outcome Measure Information:
Title
Ability of palliative capecitabine and gemcitabine
Description
Determine the ability of palliative capecitabine and gemcitabine to maintain or improve tumor-related symptoms (after treatable biliary duct obstruction has been relieved) as measured by the clinical benefit response.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinical benefit response alone as measured after 3 courses
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed biliary tract cancer Locally advanced, unresectable, or metastatic disease Metastatic adenocarcinoma with clinical documentation of gallbladder or bile tree involvement with no evidence of another primary adenocarcinoma allowed Measurable or nonmeasurable disease Treatable biliary duct obstruction must be relieved by either internal endoscopic drainage/stenting or palliative bypass surgery before study entry Symptomatic biliary tract cancer and has at least 1 of the following: Karnofsky 60-80% Baseline analgesic consumption at least 10 mg of morphine equivalents per day Baseline pain intensity score of at least 20 mm out of a possible 100 mm No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: Age 18 to 80 Performance status See Disease Characteristics Karnofsky 60-100% Life expectancy Not specified Hematopoietic Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL Hepatic Bilirubin no greater than 4 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN AST and ALT no greater than 5 times ULN Renal Creatinine clearance greater than 50 mL/min Cardiovascular No uncontrolled cardiovascular disease Gastrointestinal Able to ingest oral medication No malabsorption syndrome No intractable nausea and/or vomiting No partial small bowel obstruction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study participation No active autoimmune disease No uncontrolled diabetes No known hypersensitivity to fluorouracil No known dihydropyrimidine dehydrogenase deficiency No definitive contraindication to corticosteroids No prior significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) that would preclude understanding or providing informed consent No prior severe reaction to fluoropyrimidine therapy No psychiatric disorder, cognitive dysfunction, or language problem that would preclude filling out the quality of life questionnaire or patient diary No other serious underlying medical condition that would preclude study participation No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy No prior immunotherapy Chemotherapy No prior chemotherapy for advanced/metastatic disease No prior palliative chemotherapy Endocrine therapy No concurrent megestrol Radiotherapy More than 4 weeks since prior radiotherapy No concurrent radiotherapy Treatment of a single painful lesion allowed Surgery See Disease Characteristics Prior Whipple procedure allowed Prior duodenal bypass allowed No concurrent endoscopic or external biliary drainage as a consequence of progressive malignant bile duct obstruction Drainage as a consequence of nonmalignant bile duct obstruction allowed Other More than 30 days since prior treatment within a clinical study No other concurrent anticancer drugs No other concurrent investigational drugs No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Koeberle, MD
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18669454
Citation
Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Kohne CH, Mingrone W, Stemmer SM, Tamas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. doi: 10.1200/JCO.2007.15.6240.
Results Reference
result
PubMed Identifier
18669455
Citation
Koeberle D, Saletti P, Borner M, Gerber D, Dietrich D, Caspar CB, Mingrone W, Beretta K, Strasser F, Ruhstaller T, Mora O, Herrmann R; Swiss Group for Clinical Cancer Research. Patient-reported outcomes of patients with advanced biliary tract cancers receiving gemcitabine plus capecitabine: a multicenter, phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol. 2008 Aug 1;26(22):3702-8. doi: 10.1200/JCO.2008.16.5704.
Results Reference
result

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Adjuvant Palliative Capecitabine and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Biliary Tract Cancer

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