Pancreatic NeoplasmsPhase 2NCT00261092
GEMOX: Oxaliplatin in Pancreatic Cancer
A Phase 2 study testing Oxaliplatin in people with Pancreatic Neoplasms, run by Sanofi at 1 site in South Korea.
Trial summary
Primary objective: To evaluate overall response rate (based on RECIST criterion) Secondary objective: To evaluate time to progression, clinical benefit, quality of life and safety Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Oxaliplatin
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2005to not given
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the pancreas
- Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data)
- Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors>2cm using conventional CT scan or ≥1cm with spiral CT scan)
- No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted
- Karnofsky Performance Status (KPS) ≥60
- No known Central Nervous System metastases
Show all 16Show fewer
- No sensory neuropathy at inclusion
- Biological and hematological evaluation < 2 weeks prior to treatment administration:
- Neutrophils ≥ 1500/ mm3
- Platelets ≥ 100,000/mm3
- Alkaline phosphatases< 5X ULN(upper Limits of Normal) and Bilirubin < 1.5X ULN
- SGOT,SGPT <2.5 X ULN if no liver metastasis
- SGOT,SGPT <5 X ULN if liver metastasis
- Creatinine < 1.5 X ULN
- Baseline imaging (CT scan or Magnetic Resonance Imaging) <3 weeks before treatment administration
- Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
Who cannot join
- Corticotherapy except for anti-emetic purpose
- Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs)
- Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
- Uncontrolled or persistent hypercalcemia
- History of significant neurologic or psychiatric disorders
- Vater ampulomas and biliary tract adenocarcinomas
- Other -non cured- malignancies
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer
Primary objective:
- To evaluate overall response rate (based on RECIST criterion)
Secondary objective:
- To evaluate time to progression, clinical benefit, quality of life and safety
- Conditions
- Pancreatic Neoplasms
- Being tested
- Oxaliplatin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate based on RECIST criteria
Secondary outcomes (4)
Time to progression
Overall survival
Clinical benefit
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startOct 2005
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.
- More trials run by SanofiThe 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
- 48 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Won-Sik Lee, MD, Study director, sanofi-avents
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261092
- Sponsor's protocol ID
- PM_L_0126
- Status last verified
- Apr 2008
- First submitted
- 1 Dec 2005
- Last updated
- 15 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00261092
- Acronym / sponsor ID
- PM_L_0126
- Conditions
- Pancreatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- First posted
- 2 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.
Primary objective:
- To evaluate overall response rate (based on RECIST criterion)
Secondary objective:
- To evaluate time to progression, clinical benefit, quality of life and safety
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically proven adenocarcinoma of the pancreas
- Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data)
- Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors>2cm using conventional CT scan or ≥1cm with spiral CT scan)
- No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted
- Karnofsky Performance Status (KPS) ≥60
Key exclusion criteria (8 listed)
- Corticotherapy except for anti-emetic purpose
- Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs)
- Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
- Uncontrolled or persistent hypercalcemia
- History of significant neurologic or psychiatric disorders
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 |
|---|---|---|
| Oxaliplatin | Drug | – |
Primary outcome
Overall response rate based on RECIST criteria
4 secondary outcomes
Time to progression
Overall survival
Clinical benefit
Quality of life
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 15 Apr 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.
Won-Sik Lee, MD study director
sanofi-avents
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 Oxaliplatin in people with Pancreatic Neoplasms, run by Sanofi 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 16 inclusion and 8 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 15 Apr 2008. 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?
Overall response rate based on RECIST criteria. 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 15 Apr 2008.