Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function (FOLFOX4)
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|ClinicalTrials.gov Identifier: NCT00094965|
Recruitment Status : Completed
First Posted : October 29, 2004
Last Update Posted : March 30, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancer||Drug: Oxaliplatin (SR96669)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
Drug: Oxaliplatin (SR96669)
oxaliplatin in combination with FOLFOX4
- Adverse events. [ Time Frame: 12 Cycles ]
- Pharmacokinetics. [ Time Frame: 2 Cycles ]
- Tumor evaluations for response or progressive disease. [ Time Frame: 12 Cycles ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094965
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6307|
|Study Director:||ICD CSD||Sanofi|