Stomach NeoplasmsPhase 2NCT00611507
A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer
A Phase 2 study testing Oxaliplatin, 5-Fluorouracil in people with Stomach Neoplasms, run by Sanofi at 1 site in Colombia.
Trial summary
This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Oxaliplatin, 5-Fluorouracil
- Type of treatment
- Injection or infusion
- How many people
- 21 participants
- Where
- 1 siteColombia
- Study dates
- Nov 2002to Apr 2004
- 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
- Histologically proven gastric or gastroesophagic junction adenocarcinoma
- Measurable disease at least in a unidimensional manner. If a unique metastasis constitutes the only disease symptom, histological confirmation will be required
- Metastatic or locally non-surgical primary gastric cancer
- Recurrent gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant chemo-radiotherapy of at least 6 months
- Serum bilirubin< 2 mg/dl
- Serum creatinine < or =to 2 times normal superior limit
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- Absolute neutrophil count > or =to 2000/dl
- Platelet count > or =to 100000/dl
- Hemoglobin > or =to 10 g/dl
- AST/ALT < or =to 2.5 times normal superior institutional limit
- Alkaline phosphatase < or =to 5 times the normal superior institutional limit
- Age > 18 years
- Performance Status ECOG 0-2
- Written informed consent signed and dated
Who cannot join
- Symptomatic sensory peripheral neuropathy
- Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial hypertension)
- Any other malignancy diagnosed within 5 years previous to the gastric cancer, with the exception of " in situ " cervix carcinoma or non-melanoma skin cancer
- Concomitant anti-tumoral treatment
- Cerebral metastases
- Unstable heart disease, even though under treatment
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- Myocardial infarction within the last 6 months
- Pregnancy or nursing (or women in reproductive life without adequate contraception)
- Significant neurological or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer
- Conditions
- Stomach Neoplasms
- Being tested
- Oxaliplatin, 5-Fluorouracil
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin, 5-FluorouracilDrug
Also called Eloxatin, 5FU
5FU 500 mg/m² per week in IV bolus infusion during 30 min AF 20mg/m²/week in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg/m² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate - RECIST criteria (unidimensional)
Measured: During the study conduct
Secondary outcomes (1)
Progression-free Survival (PFS)
Measured: During the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startNov 2002
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Juan Carlos Gomez, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611507
- Sponsor's protocol ID
- L_8107
- Status last verified
- Mar 2008
- First submitted
- 28 Jan 2008
- Last updated
- 25 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00611507
- Acronym / sponsor ID
- L_8107
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Apr 2004 (actual)
- First posted
- 11 Feb 2008 (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.
This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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)
- Histologically proven gastric or gastroesophagic junction adenocarcinoma
- Measurable disease at least in a unidimensional manner. If a unique metastasis constitutes the only disease symptom, histological confirmation will be required
- Metastatic or locally non-surgical primary gastric cancer
- Recurrent gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant chemo-radiotherapy of at least 6 months
- Serum bilirubin< 2 mg/dl
Key exclusion criteria (9 listed)
- Symptomatic sensory peripheral neuropathy
- Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial hypertension)
- Any other malignancy diagnosed within 5 years previous to the gastric cancer, with the exception of " in situ " cervix carcinoma or non-melanoma skin cancer
- Concomitant anti-tumoral treatment
- Cerebral metastases
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, 5-FluorouracilAlso: Eloxatin, 5FU5FU 500 mg/m² per week in IV bolus infusion during 30 min AF 20mg/m²/week in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg/m² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest. | Drug | – |
Primary outcome
Response rate - RECIST criteria (unidimensional)
Time frame: During the study conduct
1 secondary outcome
Progression-free Survival (PFS)
Time frame: During the study conduct
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 25 Mar 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.
Juan Carlos Gomez study director
Sanofi
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, 5-Fluorouracil in people with Stomach Neoplasms, run by Sanofi at 1 site in Colombia.
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 9 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 25 Mar 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 Colombia. 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?
Response rate - RECIST criteria (unidimensional) (time frame: During the study conduct). 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 25 Mar 2008.