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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 is a Phase 2 study of Gastrointestinal Cancer that has completed, run by Sanofi. The registered enrollment target is 43 participants, below the 233-participant average among 48 other Gastrointestinal Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00094965
The ClinicalTrials.gov registry entry for NCT00094965 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 233-participant average among 48 other Gastrointestinal Cancer trials with a reported enrollment target (82% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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