Official Title: “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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Study Primary Completion Date: May 2006

Intervention(s) in this Clinical Trial

• Drug: ZD6474 (vandetanib)
  • once daily oral tablet
• Drug: Irinotecan
  • intravenous infusion
• Drug: 5-Fluorouracil
  • intravenous infusion
• Drug: Leucovorin
  • intravenous infusion

Primary Measures

• 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
  • Time Frame: assessed at each visit
    Safety Issue?: No

Inclusion Criteria:

• 1. Confirmed metastatic colorectal adenocarcinoma
• 2. Not amenable to surgery or radiation therapy
• 3. 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Mark Saunders, MD Principal Investigator AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00507091

Study ID Number: D4200C00038

ClinicalTrials.gov Identifier: NCT00507091

Health Authority: United Kingdom: National Health Service