Extrahepatic Bile Duct CancerPhase 2NCT00073905
Adjuvant Palliative Capecitabine and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Biliary Tract Cancer
A Phase 2 study testing capecitabine plus gemcitabine in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
- What is being tested?
- capecitabine plus gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2003to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial
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.
Read the 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.
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer, Pain
- Being tested
- capecitabine plus gemcitabine
- 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
- Medical subject headings
- Bile Duct Neoplasms, Gallbladder Neoplasms, Liver Neoplasms, Pain, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine plus gemcitabineDrug
capecitabine plus gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Capecitabine plus Gemcitabine Receives: Drug: capecitabine plus gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Clinical benefit response alone as measured after 3 courses
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2003 (estimated)
- Study startApr 2003
- Primary completionJun 2006
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extrahepatic Bile Duct CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dieter Koeberle, MD, Study chair, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073905
- Sponsor's protocol ID
- SAKK 44/02
- Other IDs
- EU-20322
- Status last verified
- Jun 2012
- First submitted
- 10 Dec 2003
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18669454Koeberle 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.
PubMed 18669455
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial
- ClinicalTrials.gov ID
- NCT00073905
- Acronym / sponsor ID
- SAKK 44/02
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: capecitabine plus gemcitabineCapecitabine plus Gemcitabine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine plus gemcitabinecapecitabine plus gemcitabine | Drug | Arm A |
Primary outcome
Ability of palliative capecitabine and gemcitabine
Time frame: 3 months
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.
1 secondary outcome
Clinical benefit response alone as measured after 3 courses
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
- Results publication: PubMed 18669454Bernhard 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 publication: PubMed 18669455Koeberle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Koeberle, MD study chair
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine plus gemcitabine in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of palliative capecitabine and gemcitabine (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00073905, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.