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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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00507091
Enrollment
24
Registered
2007-07-25
Start date
2005-08-31
Completion date
2008-06-30
Last updated
2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma, Colorectal, Metastatic

Keywords

ZD6474, Irinotecan, 5-Fluorouracil, Leucovorin, colorectal

Brief summary

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.

Interventions

DRUGIrinotecan

intravenous infusion

DRUG5-Fluorouracil

intravenous infusion

DRUGLeucovorin

intravenous infusion

DRUGZD6474 (vandetanib) 300mg

once daily oral tablet

DRUGZD6474 (vandetanib) 100mg

once daily oral tablet

Sponsors

Genzyme, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 examinationsassessed at each visit

Countries

Belgium, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026