Text Size

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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00233623
First received: October 4, 2005
Last updated: January 25, 2011
Last verified: January 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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: July 2004
Estimated Study Completion Date: January 2006
Estimated Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  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
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
AstraZeneca
Investigators
Study Director: AstraZeneca Italy Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00233623     History of Changes
Other Study ID Numbers: 1839IL/0138
Study First Received: October 4, 2005
Last Updated: January 25, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by AstraZeneca:
Metastatic Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Irinotecan
Gefitinib
Leucovorin
 Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on May 22, 2013