Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination - Tabular View

Tracking Information

First Received Date ^ICMJE

July 10, 2007

Last Updated Date

April 3, 2009

Start Date ^ICMJE

August 2005

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Establish the safety & efficacy of ZD6474 w/5-fluorouracil,lecovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, haematology, urinalysis, ECG and physical examinations

Change History

Complete list of historical versions of study NCT00507091 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Official Title ^ICMJE

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.

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Metastatic
Colorectal
Adenocarcinoma

Intervention ^ICMJE

Drug: ZD6474 (vandetanib)
Drug: Irinotecan
Drug: 5-Fluorouracil
Drug: Leucovorin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Confirmed metastatic colorectal adenocarcinoma
Not amenable to surgery or radiation therapy
For first or second line chemotherapy

Exclusion Criteria:

Brain metastases or spinal compression
Last prior chemotherapy discontinued within 4 weeks before start
Last dose radiotherapy within 4 weeks of start

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00507091

Responsible Party

Study ID Numbers ^ICMJE

D4200C00038

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Mark Saunders, MD	AstraZeneca
Study Director:	Peter Langmuir	AstraZeneca

Information Provided By

AstraZeneca

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP