Pancreatic CancerPhase 3NCT00268411
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
A Phase 3 study testing gemcitabine hydrochloride and oxaliplatin in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- gemcitabine hydrochloride and oxaliplatin
- How many people
- 80 participants
- Where
- 15 sitesFrance
- Study dates
- Sep 2004to not given
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
- Measurable disease (primary tumor or metastasis)
- At least 1 cm in diameter by spiral CT scan
- No ampulla of Vater carcinoma or biliary adenocarcinoma
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Life expectancy more than 12 weeks
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Alkaline phosphatase < 5 times normal
- Bilirubin < 1.5 times normal
- Creatinine < 1.5 times normal
- No pre-existing neuropathy
- No unstable or uncontrolled pain
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No serious cardiovascular disease
- No serious respiratory disease
- No uncontrolled or persistent hypercalcemia
- No psychological, familial, social, or geographical condition that would preclude study treatment
- No other active malignancy
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No concurrent corticosteroids
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Hopital Duffaut
Avignon, 84902
C.H.G. Beauvais
Beauvais, 60021
Hopital Drevon
Dijon, 21000
Centre Hospitalier de Dreux
Dreux, 28100
Centre Hospitalier Departemental
La Roche-sur-Yon, F-85025
Hopital Saint - Louis
La Rochelle, 17000
Hopital Louis Pasteur - Le Coudray
Le Coudray, 28630
Clinique Victor Hugo
Le Mans, F-72000
Polyclinique des Quatre Pavillons
Lormont, 33310
Clinique Saint Jean
Lyon, 69008
Hopital Saint Antoine
Paris, 75571
Hopital Tenon
Paris, 75970
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Polyclinique De Courlancy
Reims, F-51100
C.H. Senlis
Senlis, 60309
About this study
Official title: Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.
PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.
Secondary
- Compare the clinical benefits and tolerability of these regimens in these patients.
- Compare the progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.
In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- gemcitabine hydrochloride, oxaliplatin
- Keywords
- adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Secondary outcomes (2)
Clinical benefits and tolerability
Progression-free and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Christophe Louvet, MD, PhD, Study chair, Hopital Saint Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268411
- Sponsor's protocol ID
- CDR0000453849
- Other IDs
- GERCOR-D04-1-GEMOX, EU-20569, SANOFI-GERCOR-D04-1-GEMOX
- Status last verified
- May 2007
- First submitted
- 20 Dec 2005
- Last updated
- 27 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
- ClinicalTrials.gov ID
- NCT00268411
- Acronym / sponsor ID
- CDR0000453849
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Sep 2004
- First posted
- 22 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.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.
PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.
Secondary
- Compare the clinical benefits and tolerability of these regimens in these patients.
- Compare the progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.
In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
| oxaliplatin | Drug | – |
Primary outcome
Objective response rate
2 secondary outcomes
Clinical benefits and tolerability
Progression-free and overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2008.
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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.
Christophe Louvet, MD, PhD study chair
Hopital Saint Antoine
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gemcitabine hydrochloride and oxaliplatin in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 15 sites in France.
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: status not confirmed, as of the sponsor's last update on 27 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Objective 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 27 May 2008.