Stomach NeoplasmsPhase 2NCT00263354
Oxaliplatin in Gastric Cancer
A Phase 2 study testing Oxaliplatin in people with Stomach Neoplasms, run by Sanofi.
Trial summary
To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric 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
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status of 0-2.
- Histologically proven gastric or gastro-esophageal junction adenocarcinoma.
- At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation.
- First line locally unresectable or metastatic gastric cancer.
- Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months.
- Serum bilirubin < 2 mg/dl
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- Serum creatinine < or = 2 mg/dl
- Hemoglobin > or = 10 g/dl
- Absolute neutrophil count > or = 2000/dl
- Platelet count >or = 100, 000/dl
- AST/ALT < or = 2.5 time-fold the institutional normal upper limit
- Alkaline phosphatase < or = 5 time-fold the institutional normal upper limit
- Imagenological evaluation of the patient at least 2 weeks prior to the drug infusion
- Laboratory tests at least 1 week prior to the first infusion
- Patient available for follow up and able to answer to the quality of life questionnaire
Who cannot join
- Symptomatic sensorial peripheral neuropathy
- Uncontrolled concomitant disease
- Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer
- Concomitant antitumoral treatment
- Cerebral metastases
- Unstable heart disease, even though in treatment
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- Myocardial infarction within the last 6 months
- Radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy within the last 6 months.
- Pregnancy or nursing ( or women in reproductive life without adequate contraception)
- Significant neurological or psychiatric disorders.
About this study
Official title: Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.
To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.
- Conditions
- Stomach Neoplasms
- Being tested
- Oxaliplatin
- Medical subject headings
- Stomach 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.
To evaluate response rate according to RECIST criteria
To evaluate the progression-free survival in the ITT population
Secondary outcomes (2)
To evaluate the overall survival in the ITT population
To investigate safety using NCI-CTC criteria version 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startOct 2003
- Primary completionJul 2006
- Study completionJul 2006
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jesus M. Ruiz, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263354
- Sponsor's protocol ID
- L_8915
- Status last verified
- Aug 2010
- First submitted
- 7 Dec 2005
- Last updated
- 9 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.
- ClinicalTrials.gov ID
- NCT00263354
- Acronym / sponsor ID
- L_8915
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 8 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.
To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (15 listed)
- ECOG performance status of 0-2.
- Histologically proven gastric or gastro-esophageal junction adenocarcinoma.
- At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation.
- First line locally unresectable or metastatic gastric cancer.
- Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months.
Key exclusion criteria (10 listed)
- Symptomatic sensorial peripheral neuropathy
- Uncontrolled concomitant disease
- Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer
- Concomitant antitumoral 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 | Drug | – |
Primary outcome
To evaluate response rate according to RECIST criteria
To evaluate the progression-free survival in the ITT population
2 secondary outcomes
To evaluate the overall survival in the ITT population
To investigate safety using NCI-CTC criteria version 2
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 9 Nov 2010.
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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.
Jesus M. Ruiz, MD study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin in people with Stomach Neoplasms, run by Sanofi.
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 15 inclusion and 10 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 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
To evaluate response rate according to RECIST criteria. The study lists 2 primary outcomes in all. 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 9 Nov 2010.