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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233623
Recruitment Status : Withdrawn
First Posted : October 6, 2005
Last Update Posted : January 27, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Iressa (Gefitinib) Drug: Irinotecan Drug: 5Fluorouracil Drug: Leucovorin Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2004
Estimated Primary Completion Date : January 2006
Estimated Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Time to progression (6 months after Last patient in)

Secondary Outcome Measures :
  1. Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00233623

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Research Center
Bari, Italy
Research Site
Bergamo, Italy
Research Site
Catania, Italy
Research Site
Cremona, Italy
Research Site
Cuneo, Italy
Research Site
L'Aquila, Italy
Research Site
La Spezia, Italy
Research Site
Milano, Italy
Research Site
Palermo, Italy
Research Site
Pescara, Italy
Research Site
Rozzano, Italy
Research Site
Torino, Italy
Research Site
Venezia, Italy
Sponsors and Collaborators
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Study Director: AstraZeneca Italy Medical Director, MD AstraZeneca

Layout table for additonal information Identifier: NCT00233623    
Other Study ID Numbers: 1839IL/0138
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Metastatic Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors