Pancreatic NeoplasmsPhase 2NCT00268840
The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
A Phase 2 study testing Docetaxel and Gemcitabine in people with Pancreatic Neoplasms and Biliary Tract Neoplasms, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pancreatic Neoplasms, Biliary Tract Neoplasms
- What is being tested?
- Docetaxel and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2001to Feb 2006
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 years or older
- Patients must sign informed consent prior to study entry
- Patients has Karnofsky performance status of more than 50%
- No prior chemotherapy
- Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer
- No previous radiotherapy for locally advanced or metastases.
- Hematopoietic: WBC > 3000/mm2, Absolute neutrophile count > 1500/mm2, Hemoglobin > 9g/dl, Platelet count > 100 000/mm2
Who cannot join
- No intracerebral or meningeal metastases
- Pregnant
- Fertile patient must use effective contraception
- No other serious medical condition or illness that would preclude study participation
- Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT > 3.5 times upper limit of normal(ULN) alkaline phosphatase > 6 times upper limit of normal(ULN)
- More than 30 days since prior investigational therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery
The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.
Read the detailed description
Try a new drug association on this advanced cancer
- Conditions
- Pancreatic Neoplasms, Biliary Tract Neoplasms
- Being tested
- Docetaxel, Gemcitabine
- Keywords
- Pancreas or biliary cancer
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called TAXOTERE
Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
GemcitabineDrug
Also called GEMZAR
Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines
| Study group | Role | What they receive |
|---|---|---|
| unique | Experimental | Taxotère - Gemzar Receives: Drug: Docetaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Secondary outcomes (4)
Clinical benefit
Progression-free survival
Overall survival
To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startAug 2001
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Investigators
- Chauvenet Laure, MD, Study chair, ARCAGY/ GINECO GROUP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268840
- Sponsor's protocol ID
- RIO PANCREAS
- Status last verified
- Jun 2011
- First submitted
- 22 Dec 2005
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery
- ClinicalTrials.gov ID
- NCT00268840
- Acronym / sponsor ID
- RIO PANCREAS
- Conditions
- Pancreatic Neoplasms, Biliary Tract Neoplasms
- Keywords
- Pancreas or biliary cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 23 Dec 2005 (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 purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.
Detailed description
Try a new drug association on this advanced cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unique | Experimental | Drug: Docetaxel, Drug: GemcitabineTaxotère - Gemzar |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged 18 years or older
- Patients must sign informed consent prior to study entry
- Patients has Karnofsky performance status of more than 50%
- No prior chemotherapy
- Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer
Key exclusion criteria (6 listed)
- No intracerebral or meningeal metastases
- Pregnant
- Fertile patient must use effective contraception
- No other serious medical condition or illness that would preclude study participation
- Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT > 3.5 times upper limit of normal(ULN) alkaline phosphatase > 6 times upper limit of normal(ULN)
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 |
|---|---|---|
| DocetaxelAlso: TAXOTEREDocetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines | Drug | unique |
| GemcitabineAlso: GEMZARGemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines | Drug | unique |
Primary outcome
Overall response rate
4 secondary outcomes
Clinical benefit
Progression-free survival
Overall survival
To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel
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 30 Jun 2011.
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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.
Chauvenet Laure, MD study chair
ARCAGY/ GINECO GROUP
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 Docetaxel and Gemcitabine in people with Pancreatic Neoplasms and Biliary Tract Neoplasms, run by ARCAGY/ GINECO GROUP at 1 site in France.
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 7 inclusion and 6 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 30 Jun 2011. 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 France. 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?
Overall response rate. 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 30 Jun 2011.