Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic; Colorectal; Adenocarcinoma
Intervention: ZD6474 (vandetanib) (Drug); Irinotecan (Drug); 5-Fluorouracil (Drug); Leucovorin (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Mark Saunders, MD, Principal Investigator, Affiliation: AstraZeneca
Peter Langmuir, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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.
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Research Site, Gent, Belgium
Research Site, Manchester, United Kingdom
Research Site, Belfast, United Kingdom
Additional Information
Starting date: August 2005
Ending date: March 2008
Last updated: December 18, 2007
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