Clinical trial · Interventional
Phase I FOLFOX Combination
A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
NCT00499850CI-TRIAL-00023651completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| ZD6474 (vandetanib) | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
- timeFrame
- Assessed at each visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV) 2. WHO performance status 0-1 3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques Exclusion Criteria: 1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable 2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment 3. prior unanticipated severe reaction to oxaliplatin
References
Publications (0)
Data not yet available
No reference posted for this study.