Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00507091

Purpose

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.

Condition	Intervention	Phase
Metastatic Colorectal Adenocarcinoma	Drug: ZD6474 (vandetanib) Drug: Irinotecan Drug: 5-Fluorouracil Drug: Leucovorin	Phase I

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

Resource links provided by NLM:

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Irinotecan U 101440E Irinotecan hydrochloride Vandetanib Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	August 2005
Study Completion Date:	June 2008
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Intervention Details:

once daily oral tablet

intravenous infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507091

Locations

Belgium
Research Site
Gent, Belgium
United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Belfast, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

Study ID Numbers:	D4200C00038
Study First Received:	July 10, 2007
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00507091 History of Changes
Health Authority:	United Kingdom: National Health Service; Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by AstraZeneca:

ZD6474
Irinotecan
5-Fluorouracil
Leucovorin
colorectal

Study placed in the following topic categories:

Antimetabolites
Vitamin B Complex
Immunologic Factors
Irinotecan
Leucovorin
Trace Elements
Folinic Acid
Immunosuppressive Agents

Carcinoma
Fluorouracil
Vitamins
Micronutrients
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Vitamin B Complex
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Irinotecan
Leucovorin
Enzyme Inhibitors

Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Vitamins
Therapeutic Uses
Fluorouracil
Micronutrients
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009