Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00233623

Purpose

The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.

Condition	Intervention	Phase
Metastatic Colorectal Cancer	Drug: Iressa (Gefitinib) Drug: Irinotecan Drug: 5Fluorouracil Drug: Leucovorin	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Non-Comparative, Multicentre, Phase II, Parallel-Group Trial Of ZD1839 (Iressa™) In Combination With 5 Fluorouracil, Leucovorin And Cpt-11 (Irinotecan) In Patients With Metastatic Colorectal Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to progression (6 months after Last patient in)

Secondary Outcome Measures:

Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)

Estimated Enrollment:	190
Study Start Date:	December 2004

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed metastatic colorectal cancer
Presence of measurable metastases
No previous treatment for metastatic cancer

Exclusion Criteria:

No presence of Central Nervous System metastases
No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233623

Locations

Italy
Research Center
Bari, Italy
Research Site
Cuneo, Italy
Research Site
Palermo, Italy
Research Site
Pescara, Italy
Research Site
Torino, Italy
Research Site
Venezia, Italy
Research Site
L'Aquila, Italy
Research Site
Cremona, Italy
Research Site
Bergamo, Italy
Research Site
Milano, Italy
Research Site
Catania, Italy
Research Site
La Spezia, Italy
Research Site
Rozzano, Italy

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Italy Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	1839IL/0138
Study First Received:	October 4, 2005
Last Updated:	July 17, 2007
ClinicalTrials.gov Identifier:	NCT00233623
Health Authority:	Italy: Ministry of Health

Keywords provided by AstraZeneca:

Metastatic Colorectal Cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Leucovorin
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Gefitinib
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Protein Kinase Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009