Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer. - Full Text View

Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.

This study has been terminated.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00065117

Purpose

The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic Colorectal Cancer.

Condition	Intervention	Phase
Colorectal Neoplasms Metastases, Neoplasm	Drug: ZD6126 Drug: Placebo Drug: 5-fluorouracil Drug: leucovorin Drug: oxaliplatin	Phase II

MedlinePlus related topics:

Cancer Colorectal Cancer

ChemIDplus related topics:

Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by AstraZeneca:

Estimated Enrollment:

180

Eligibility

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

Criteria

Inclusion Criteria:

Metastatic colorectal carcinoma
Suitable for first-line treatment of metastatic disease

Exclusion Criteria:

Peripheral neuropathy greater than Grade 1
Adjuvant therapy within 6 months prior to study treatment
Prior oxaliplatin
Prior pelvic or whole abdomen radiation
Any history of coronary angioplasty or history of myocardial infarction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065117

Locations


United States, California
	Research Site
	San Francisco, California, United States
	Research Site
	Los Angeles, California, United States

United States, Illinois
	Research Site
	Chicago, Illinois, United States

United States, Louisiana
	Research Site
	New Orleans, Louisiana, United States

United States, Maryland
	Research Site
	Baltimore, Maryland, United States

United States, Missouri
	Research Site
	St. Louis, Missouri, United States

United States, New York
	Research Site
	New York, New York, United States

United States, North Carolina
	Research Site
	Chapel Hill, North Carolina, United States
	Research Site
	Durham, North Carolina, United States

United States, Pennsylvania
	Research Site
	Pittsburgh, Pennsylvania, United States

Sponsors and Collaborators

AstraZeneca

More Information

Study ID Numbers:	D2820C00007, 6126IL/00007
First Received:	July 17, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00065117
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

metastatic

colorectal

first-line

adjuvant

cancer

Colorectal Cancer

Colorectal Carcinoma

Colorectal Tumors

Neoplasms, Colorectal

metastatic

Study placed in the following topic categories:

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Leucovorin

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Carcinoma

Oxaliplatin

Digestive System Diseases

Fluorouracil

Neoplasm Metastasis

Gastrointestinal Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Vitamin B Complex

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplastic Processes

Neoplasms by Site

Pathologic Processes

Vitamins

Therapeutic Uses

Micronutrients

ClinicalTrials.gov processed this record on October 17, 2008