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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00094965 |
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 | Intervention | Phase |
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Gastrointestinal Cancer |
Drug: Oxaliplatin (SR96669) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety 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 |
Enrollment: | 43 |
Study Start Date: | September 2004 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Oxaliplatin (SR96669)
oxaliplatin in combination with FOLFOX4
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | POP5347 |
Study First Received: | October 28, 2004 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00094965 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Gastrointestinal tumors and normal to severely abnormal renal function |
Oxaliplatin Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Fluorouracil Gastrointestinal Neoplasms |
Oxaliplatin Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Antineoplastic Agents Gastrointestinal Diseases Therapeutic Uses Gastrointestinal Neoplasms Pharmacologic Actions |