Gastrointestinal CancerPhase 2FOLFOX4NCT00094965
Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function
A Phase 2 study testing Oxaliplatin (SR96669) in people with Gastrointestinal Cancer, run by Sanofi at 1 site in United States.
Trial summary
This trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal dysfunction) based on their baseline measured creatinine clearance then treated with FOLFOX4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Oxaliplatin (SR96669)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2007
- 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
- Patients must have histologically or cytologically confirmed locally advanced or metastatic gastrointestinal (GI) malignancy;
- Patients may have measurable or non-measurable disease;
- Prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are allowed, with the exception that patients cannot have had prior treatment with oxaliplatin, cisplatin or other nephrotoxic anticancer agent;
- Patients must have had no chemotherapy or radiotherapy within 4 weeks (28 days) prior to entering the study;
- Age 18 or older;
- Karnofsky performance status of 70% or greater for patients with normal or mildly abnormal renal function and 50% or greater for patients with moderately or severely abnormal renal function;
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- Life expectancy of at least 3 months;
- Adequate bone marrow function (WBC > or = 3000 cells/mm3, ANC > or = 1500 cells/mm3, platelets > or = 100,000 cells/mm3);
- Adequate liver function (total bilirubin < or =1.5 times the institutional upper limit of normal (IULN), AST (SGOT)/ALT (SGPT) < or = 2 times the IULN, unless liver metastases are present and documented at baseline by CT or MRI scan (< or = 5 times IULN in that case), alkaline phosphatase < or = 2 times the IULN, unless liver metastases are present and documented at baseline by CT or MRI scan (< or = 5 times IULN in that case));
- Patients may have a Grade 1 neurotoxicity at study entry. Absence of deep tendon reflexes as a sole neurological abnormality does not render the patient ineligible;
- If female, not pregnant or lactating at inclusion. Documentation of a negative serum HCG pregnancy test for women of child bearing potential is required at inclusion;
- Women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and for 6 months after discontinuation of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately;
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with active hydronephrosis (patients with a functioning ureteral stent are allowed on study);
- Patients who have had chemotherapy or radiotherapy within 4 weeks (28 days) prior to entering the study;
- Patients who have had a major surgery within 4 weeks (28 days) prior to entering the study;
- Patients who had prior therapy with oxaliplatin, cisplatin or other nephrotoxic anticancer agent;
- History of allergy to platinum compounds;
- Patients undergoing therapy with other investigational agents. Patients who received any investigational drug must have discontinued the investigational drug 30 days or more before beginning treatment on this study;
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- Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Patients who have had a history of cardiac toxicities while on 5FU/LV therapy or myocardial infarction < or = 6 months prior to study entry;
- Patients with known brain metastases because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other toxicities;
- Patients with interstitial pneumonia or extensive and symptomatic fibrosis of the lungs;
- Patients with uncontrolled intercurrent illness (high blood pressure, unstable angina pectoris, symptomatic congestive heart failure (NYHA III or IV), severe cardiac arrhythmia, uncontrolled diabetes or active infection);
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6307
About this study
Official title: Phase II Trial of Oxaliplatin in Combination With Bolus/Infusional 5FU/LV (FOLFOX4) in Patients With Advanced Gastrointestinal (GI) Cancers With Varying Degrees of Renal Impairment
This trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal dysfunction) based on their baseline measured creatinine clearance then treated with FOLFOX4.
Standard bone marrow and liver function inclusion and exclusion criteria must be met prior to study treatment. FOLFOX4 in the study is given every 2 weeks (1 cycle = 2 weeks) for up to 12 cycles unless there are treatment delays to allow for recovery from toxic effects. Dose modifications are included for protocol specified toxicities. After 12 treatment cycles on study, patients who are having a beneficial disease response may continue to have oxaliplatin supplied off study to continue the treatment regimen until disease progression, prohibitive toxicity or death.
Oxaliplatin pharmacokinetic studies (plasma and urine) are planned during cycles 1 and 2 on each patient. Creatinine clearance will be assessed every 2 cycles and disease status will be assessed every 3 cycles of treatment during the study.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Oxaliplatin (SR96669)
- Keywords
- Advanced Gastrointestinal tumors and normal to severely abnormal renal function
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin (SR96669)Drug
oxaliplatin in combination with FOLFOX4
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Oxaliplatin (SR96669) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events.
Measured: 12 Cycles
Secondary outcomes (2)
Pharmacokinetics.
Measured: 2 Cycles
Tumor evaluations for response or progressive disease.
Measured: 12 Cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2004 (estimated)
- Study startSep 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094965
- Sponsor's protocol ID
- POP5347
- Acronym
- FOLFOX4
- Status last verified
- Mar 2009
- First submitted
- 28 Oct 2004
- Last updated
- 30 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Oxaliplatin in Combination With Bolus/Infusional 5FU/LV (FOLFOX4) in Patients With Advanced Gastrointestinal (GI) Cancers With Varying Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT00094965
- Acronym / sponsor ID
- FOLFOX4 / POP5347
- Conditions
- Gastrointestinal Cancer
- Keywords
- Advanced Gastrointestinal tumors and normal to severely abnormal renal function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 29 Oct 2004 (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 trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal dysfunction) based on their baseline measured creatinine clearance then treated with FOLFOX4.
Standard bone marrow and liver function inclusion and exclusion criteria must be met prior to study treatment. FOLFOX4 in the study is given every 2 weeks (1 cycle = 2 weeks) for up to 12 cycles unless there are treatment delays to allow for recovery from toxic effects. Dose modifications are included for protocol specified toxicities. After 12 treatment cycles on study, patients who are having a beneficial disease response may continue to have oxaliplatin supplied off study to continue the treatment regimen until disease progression, prohibitive toxicity or death.
Oxaliplatin pharmacokinetic studies (plasma and urine) are planned during cycles 1 and 2 on each patient. Creatinine clearance will be assessed every 2 cycles and disease status will be assessed every 3 cycles of treatment during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oxaliplatin (SR96669) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have histologically or cytologically confirmed locally advanced or metastatic gastrointestinal (GI) malignancy;
- Patients may have measurable or non-measurable disease;
- Prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are allowed, with the exception that patients cannot have had prior treatment with oxaliplatin, cisplatin or other nephrotoxic anticancer agent;
- Patients must have had no chemotherapy or radiotherapy within 4 weeks (28 days) prior to entering the study;
- Age 18 or older;
Key exclusion criteria (12 listed)
- Patients with active hydronephrosis (patients with a functioning ureteral stent are allowed on study);
- Patients who have had chemotherapy or radiotherapy within 4 weeks (28 days) prior to entering the study;
- Patients who have had a major surgery within 4 weeks (28 days) prior to entering the study;
- Patients who had prior therapy with oxaliplatin, cisplatin or other nephrotoxic anticancer agent;
- History of allergy to platinum compounds;
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 (SR96669)oxaliplatin in combination with FOLFOX4 | Drug | 1 |
Primary outcome
Adverse events.
Time frame: 12 Cycles
2 secondary outcomes
Pharmacokinetics.
Time frame: 2 Cycles
Tumor evaluations for response or progressive disease.
Time frame: 12 Cycles
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 30 Mar 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.
ICD CSD 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 (SR96669) in people with Gastrointestinal Cancer, run by Sanofi at 1 site in United States.
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 12 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 30 Mar 2009. 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 United States. 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?
Adverse events. (time frame: 12 Cycles). 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 30 Mar 2009.