Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Phase 1

Completed

• Conditions: Metastatic; Colorectal; Adenocarcinoma
• Interventions: Drug: ZD6474 (vandetanib) 100mg; Drug: Irinotecan; Drug: 5-Fluorouracil; Drug: ZD6474 (vandetanib) 300mg; Drug: Leucovorin

• Registration Number: NCT00507091
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2006-05
• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-24
• Study First Posted: 2007-07-25
• Study Completion: 2008-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZD6474 (vandetanib) 300mg	ZD6474 (vandetanib) 300mg	-
ZD6474 (vandetanib) 100mg	ZD6474 (vandetanib) 100mg	-
ZD6474 (vandetanib) 100mg	5-Fluorouracil	-
ZD6474 (vandetanib) 100mg	Irinotecan	-
ZD6474 (vandetanib) 100mg	Leucovorin	-
ZD6474 (vandetanib) 300mg	Irinotecan	-
ZD6474 (vandetanib) 300mg	5-Fluorouracil	-
ZD6474 (vandetanib) 300mg	Leucovorin	-

Primary Outcome Measures

Name	Time	Method
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	assessed at each visit

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom