Carcinoma, HepatocellularPhase 2NCT00280618
Oxaliplatin in Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Oxaliplatin in people with Carcinoma, Hepatocellular, run by Sanofi.
Trial summary
Primary: To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin Secondary: Safety and tolerability of this regimen in these patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Oxaliplatin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 2004to Nov 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed hepatocellular carcinoma
- Patients must have measurable disease by CT scan
- Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy.
- The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds.
- WHO performance status: 0 to 2
- Patients must have adequate organ and marrow function as defined below:
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- Leukocytes : ≥ 3,000/μl
- Absolute neutrophil count :≥ 1,500/μl
- Platelets : ≥ 80,000/μl
- Total bilirubin : < 3.0g/dl
- ASAT/ALAT : ≤ 3 times the upper normal limits of the institute
- Creatinine : < 120μmol/l
- Patients with no evidence of clinically significant neuropathy.
Who cannot join
- Documented allergy to platinum compound or to others study's drugs
- Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
- Hematological disorder or malignancies
- Metastasis to central nervous system
- Other serious illness or medical conditions:
- Active infectious disease
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- Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia.
- Concurrent treatment with any other anticancer therapy
- Concurrent treatment with other experimental drugs.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma
Primary:
- To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin
Secondary:
- Safety and tolerability of this regimen in these patients
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Oxaliplatin
- Medical subject headings
- Carcinoma, Hepatocellular
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.
Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST
Measured: During the Study Conduct
Secondary outcomes (1)
Adverse Events collections and evaluation
Measured: From the signature of the informed consent up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startJul 2004
- Primary completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pingkuan Zhang, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280618
- Sponsor's protocol ID
- L_9202
- Status last verified
- Sep 2009
- First submitted
- 20 Jan 2006
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00280618
- Acronym / sponsor ID
- L_9202
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Nov 2006 (actual)
- First posted
- 23 Jan 2006 (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:
- To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin
Secondary:
- Safety and tolerability of this regimen in these patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (13 listed)
- Patients must have histologically confirmed hepatocellular carcinoma
- Patients must have measurable disease by CT scan
- Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy.
- The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds.
- WHO performance status: 0 to 2
Key exclusion criteria (10 listed)
- Documented allergy to platinum compound or to others study's drugs
- Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
- Hematological disorder or malignancies
- Metastasis to central nervous system
- Other serious illness or medical conditions:
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
Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST
Time frame: During the Study Conduct
1 secondary outcome
Adverse Events collections and evaluation
Time frame: From the signature of the informed consent up to the end of the study
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 Sep 2009.
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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.
Pingkuan Zhang study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin in people with Carcinoma, Hepatocellular, 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 13 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 15 Sep 2009. 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?
Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST (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 15 Sep 2009.