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NCT00094965 · ClinicalTrials.gov registry record · Phase 2
Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function
A Phase 2 study of Gastrointestinal Cancer, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT00094965: Completed Phase 2 study of Gastrointestinal Cancer, sponsored by Sanofi.
NCT00094965 is a Phase 2 study of Gastrointestinal Cancer that has completed, run by Sanofi. The registered enrollment target is 43 participants, below the 229-participant average among 49 other Gastrointestinal Cancer trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00094965, a Phase 2 study of Gastrointestinal Cancer, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study 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. 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 Studied
Interventions
- DRUG Oxaliplatin (SR96669)
Study Locations (1)
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-08 |
| Phase | Phase 2 |
What the finished NCT00094965 record still lists
NCT00094965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 229-participant average among 49 other Gastrointestinal Cancer trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Gastrointestinal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Oxaliplatin (SR96669) is the first listed.
NCT00094965 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00094965 about?
NCT00094965 is a clinical study titled "Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function". 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...
What is the current status of trial NCT00094965?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2004-09. Estimated completion is 2007-08.
What conditions does trial NCT00094965 study?
This clinical trial studies the following conditions: Gastrointestinal Cancer.
What interventions are being tested in trial NCT00094965?
The interventions under investigation include: Oxaliplatin (SR96669) (DRUG).
Who is sponsoring clinical trial NCT00094965?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00094965 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00094965's enrollment target sits among peer trials
43 39th of 49 higher than 11 of 49 other Gastrointestinal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastrointestinal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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