Advanced Biliary Tract AdenocarcinomaPhase 2NCT00504192
A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
A Phase 2 study testing Gemcitabine and Oxaliplatin in people with Advanced Biliary Tract Adenocarcinoma and Gemcitabine, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
The role of systemic chemotherapy in advanced biliary tract cancer (BTC) is known to be very limited although various single-agent or combination therapies had been tested. However, there is a possibility that palliative chemotherapy induce prolong survival and improve quality of life in advanced BTC based on several… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Biliary Tract Adenocarcinoma, Gemcitabine, Oxaliplatin
- What is being tested?
- Gemcitabine and Oxaliplatin
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed biliary tract adenocarcinoma
- Inoperable disease as defined by:
- Localized disease in a portion of the liver that does not allow the possibility of complete surgical removal of the tumor with a clear resection margin.
- Presence of metastatic lesion
- Unresectable recurrent tumor after curative resection
- anatomically resectable but inoperable associated with medical condition
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- Biliary obstruction controlled
- Minimum life expectancy of 12 weeks.
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable lesion present by imaging study
- Age over 18 years
- ECOG performance status of * 2.
- Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤3xUNL; AST and/or ALT < 5x UNL; Creatinine< 1.5mg/dl or creatinine clearance >50 ml/mins
- Consent form signed and dated prior to study specific procedures.
- Subject able to comply with the scheduled follow-up and with the management of toxicities.
Who cannot join
- Decompensated Cirrhosis or stage C (Index > 10) according to the Child-Pugh Classification
- Prior systemic chemotherapy
- Subject with reproductive potential (M/F) not using adequate contraceptive measures.
- Pregnancy and breast-feeding.
- Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
- Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
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- Symptomatic or uncontrolled brain metastasis
- Other concomitant anticancer agent, including Tamoxifen and Interferon.
- Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons.
- Participation in another clinical study or within 30 days before inclusion.
- History of severe hypersensitivity reactions to gemcitabine or oxaliplatin
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University Bucheon Hospital
Bucheon-si, Kyunggi, 420-767
About this study
Official title: A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma
The role of systemic chemotherapy in advanced biliary tract cancer (BTC) is known to be very limited although various single-agent or combination therapies had been tested. However, there is a possibility that palliative chemotherapy induce prolong survival and improve quality of life in advanced BTC based on several studies. A GERCOR study showed the promising result of gemcitabine in combination with oxaliplatin as first line chemotherapy in advanced BTC. Therefore, this phase II trial was planned to investigate efficacy and toxicity of combination chemotherapy with gemcitabine and dose adjusted oxaliplatin in patients with inoperable BTC in Korea.
Read the detailed description
Treatment scheme
:Gemcitabine 1000 mg/m2/d IV D1 as a 10mg/m2/min Oxaliplatin 85 mg/m2/d IV D2 as a 2 hours infusion
Each cycle is repeated every 2 weeks.
Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity. Subjects will be treated for at least 4 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent.
- Conditions
- Advanced Biliary Tract Adenocarcinoma, Gemcitabine, Oxaliplatin, Combination Chemotherapy, Efficacy
- Being tested
- Gemcitabine and Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine and OxaliplatinDrug
gemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
1) To estimate the overall response rate after treatment with gemcitabine and oxaliplatin in patients with advanced biliary tract adenocarcinoma
Measured: every 4 cycles
Secondary outcomes (1)
1) To evaluate the safety and tolerability of the treatment combination. 2) To estimate the time to progression and the duration of overall response. 3) To estimate overall tumor growth control rate (CR, PR plus SD). 4) To estimate overall survival.
Measured: Overall survival is defined from the first day of treatment to the date of death. Time to progression is defined from the first day of treatment to the date of tumor progression assessed by CT scan or MRI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startSep 2006
- Primary completionMar 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary Tract AdenocarcinomaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dae Sik Hong, professor, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504192
- Sponsor's protocol ID
- SCH-GO-BTC1
- Status last verified
- May 2009
- First submitted
- 18 Jul 2007
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00504192
- Acronym / sponsor ID
- SCH-GO-BTC1
- Conditions
- Advanced Biliary Tract Adenocarcinoma, Gemcitabine, Oxaliplatin, Combination Chemotherapy, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Jul 2007 (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.
The role of systemic chemotherapy in advanced biliary tract cancer (BTC) is known to be very limited although various single-agent or combination therapies had been tested. However, there is a possibility that palliative chemotherapy induce prolong survival and improve quality of life in advanced BTC based on several studies. A GERCOR study showed the promising result of gemcitabine in combination with oxaliplatin as first line chemotherapy in advanced BTC. Therefore, this phase II trial was planned to investigate efficacy and toxicity of combination chemotherapy with gemcitabine and dose adjusted oxaliplatin in patients with inoperable BTC in Korea.
Detailed description
Treatment scheme
:Gemcitabine 1000 mg/m2/d IV D1 as a 10mg/m2/min Oxaliplatin 85 mg/m2/d IV D2 as a 2 hours infusion
Each cycle is repeated every 2 weeks.
Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity. Subjects will be treated for at least 4 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with histologically or cytologically confirmed biliary tract adenocarcinoma
- Inoperable disease as defined by:
- Biliary obstruction controlled
- Minimum life expectancy of 12 weeks.
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable lesion present by imaging study
Key exclusion criteria (11 listed)
- Decompensated Cirrhosis or stage C (Index > 10) according to the Child-Pugh Classification
- Prior systemic chemotherapy
- Subject with reproductive potential (M/F) not using adequate contraceptive measures.
- Pregnancy and breast-feeding.
- Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
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 |
|---|---|---|
| Gemcitabine and Oxaliplatingemcitabine 1000mg/m2 IV on day 1 and oxaliplatin 85mg/m2 on day 2 every 2weeks | Drug | – |
Primary outcome
1) To estimate the overall response rate after treatment with gemcitabine and oxaliplatin in patients with advanced biliary tract adenocarcinoma
Time frame: every 4 cycles
1 secondary outcome
1) To evaluate the safety and tolerability of the treatment combination. 2) To estimate the time to progression and the duration of overall response. 3) To estimate overall tumor growth control rate (CR, PR plus SD). 4) To estimate overall survival.
Time frame: Overall survival is defined from the first day of treatment to the date of death. Time to progression is defined from the first day of treatment to the date of tumor progression assessed by CT scan or MRI.
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 20 May 2014.
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D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
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RecruitingPhase 1/2
SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
Solid Tumor, NSCLC
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.
Dae Sik Hong, professor principal investigator
Soonchunhyang University Hospital
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 Gemcitabine and Oxaliplatin in people with Advanced Biliary Tract Adenocarcinoma and Gemcitabine, run by Soonchunhyang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. 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 20 May 2014. 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 South Korea. 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?
1) To estimate the overall response rate after treatment with gemcitabine and oxaliplatin in patients with advanced biliary tract adenocarcinoma (time frame: every 4 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2014.