Clinical trial · Interventional
Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.
NCT00507091CI-TRIAL-00023639completedPhase 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 asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Colorectal | — | UNRESOLVED | — |
| Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| ZD6474 (vandetanib) 100mg | Drug | Vandetanib | ALIAS |
| ZD6474 (vandetanib) 300mg | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ZD6474 (vandetanib) 100mg
- interventionNames
- Drug: ZD6474 (vandetanib) 100mg
- Drug: Irinotecan
- Drug: 5-Fluorouracil
- Drug: Leucovorin
- type
- EXPERIMENTAL
- label
- ZD6474 (vandetanib) 300mg
- interventionNames
- Drug: Irinotecan
- Drug: 5-Fluorouracil
- Drug: Leucovorin
- Drug: ZD6474 (vandetanib) 300mg
Primary outcomes (1)
- measure
- Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed metastatic colorectal adenocarcinoma 2. Not amenable to surgery or radiation therapy 3. Eligible for first or second line chemotherapy Exclusion Criteria: 1. Brain metastases or spinal compression 2. Last prior chemotherapy discontinued within 4 weeks before start 3. Last dose radiotherapy within 4 weeks of start
References
Publications (1)
- BACKGROUNDSaunders MP, Wilson R, Peeters M, Smith R, Godwood A, Oliver S, Van Cutsem E. Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. Cancer Chemother Pharmacol. 2009 Sep;64(4):665-72. doi: 10.1007/s00280-008-0914-4. Epub 2009 Jan 29. PMID 19184020