Cholangiocarcinoma CancerPhase 2NCT00660699
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
A Phase 2 study testing Gemcitabine, Docetaxel and Radiation in people with Cholangiocarcinoma Cancer and Gallbladder Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma Cancer, Gallbladder Cancer, Pancreatic Cancer
- What is being tested?
- Gemcitabine, Docetaxel and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
- Patients must be 18 years or older.
- Patients must have a NCI CTC Performance Status of 0-2.
- Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
- At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
- Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for >5years
Show all 14Show fewer
- Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
- Initial Required Laboratory Values:
- Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.
- Serum creatinine should be ≤ 2 mg/dL.
- Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).
- Serum transaminases should be ≤ 5-fold the institutional upper limits.
- Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
- Patients must be able to sign an informed consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.
- Being tested
- Gemcitabine, Docetaxel, Radiation
- Keywords
- Cholangiocarcinoma, Gallbladder, Pancreatic, Ampullary, Cancer
- Medical subject headings
- Gallbladder Neoplasms, Pancreatic Neoplasms, Cholangiocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
DocetaxelDrug
Also called Taxotere
RadiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (gemcitabine, docetaxel, 5FU, radiation) | Experimental | Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Receives: Drug: Gemcitabine; Drug: Docetaxel; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Severe Toxicities
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0
Measured: 1 month after completion of treatment (treatment lasts approximately 19 weeks)
Secondary outcomes (6)
Toxicities Associated With Treatment (Grade 1-2)
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.
Measured: 30 days after completion of treatment (treatment lasts approximately 19 weeks)
Toxicities Associated With Treatment (Grade 3-4)
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.
Measured: 30 days after completion of treatment (treatment lasts approximately 19 weeks)
Disease Free Survival (DFS) - Median
DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.
Measured: Median follow-up was 24 months (range 3.2-97 months)
Overall Survival (OS) - Median
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.
Measured: Median follow-up was 24 months (range 3.2-97 months)
Overall Survival (OS)
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Measured: 1 year
Overall Survival (OS)
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startSep 2002
- Primary completionSep 2010
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cholangiocarcinoma CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Tan, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660699
- Sponsor's protocol ID
- 02-0580 / 201101866
- Status last verified
- May 2015
- First submitted
- 11 Apr 2008
- Last updated
- 27 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
- ClinicalTrials.gov ID
- NCT00660699
- Acronym / sponsor ID
- 02-0580 / 201101866
- Keywords
- Cholangiocarcinoma, Gallbladder, Pancreatic, Ampullary, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Posted 27 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (gemcitabine, docetaxel, 5FU, radiation) | Experimental | Drug: Gemcitabine, Drug: Docetaxel, Radiation: RadiationGemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) |
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 must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
- Patients must be 18 years or older.
- Patients must have a NCI CTC Performance Status of 0-2.
- Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
- At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| GemcitabineAlso: Gemzar | Drug | Arm 1 (gemcitabine, docetaxel, 5FU, radiation) |
| DocetaxelAlso: Taxotere | Drug | Arm 1 (gemcitabine, docetaxel, 5FU, radiation) |
| Radiation | Radiation | Arm 1 (gemcitabine, docetaxel, 5FU, radiation) |
Primary outcome
Incidence of Severe Toxicities
Time frame: 1 month after completion of treatment (treatment lasts approximately 19 weeks)
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0
6 secondary outcomes
Toxicities Associated With Treatment (Grade 1-2)
Time frame: 30 days after completion of treatment (treatment lasts approximately 19 weeks)
Toxicities Associated With Treatment (Grade 3-4)
Time frame: 30 days after completion of treatment (treatment lasts approximately 19 weeks)
Disease Free Survival (DFS) - Median
Time frame: Median follow-up was 24 months (range 3.2-97 months)
Overall Survival (OS) - Median
Time frame: Median follow-up was 24 months (range 3.2-97 months)
Overall Survival (OS)
Time frame: 1 year
Overall Survival (OS)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Related trials for Cholangiocarcinoma Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
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.
Benjamin Tan, M.D. principal investigator
Washington University School of Medicine
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, Docetaxel and Radiation in people with Cholangiocarcinoma Cancer and Gallbladder Cancer, run by Washington University School of Medicine at 1 site in United States.
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 1 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 27 May 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Severe Toxicities (time frame: 1 month after completion of treatment (treatment lasts approximately 19 weeks)). 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 27 May 2015; AzTrials last refreshed its copy on 7 Nov 2026.