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

NCT ID: NCT00065117

Last Updated: 2011-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Neoplasms Metastases, Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ZD6126

Intervention Type DRUG

Placebo

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

leucovorin

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Locations

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Research Site

Los Angeles, California, United States

Site Status

Research Site

San Francisco, California, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

New Orleans, Louisiana, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Research Site

St Louis, Missouri, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Chapel Hill, North Carolina, United States

Site Status

Research Site

Durham, North Carolina, United States

Site Status

Research Site

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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6126IL/00007

Identifier Type: -

Identifier Source: secondary_id

D2820C00007

Identifier Type: -

Identifier Source: org_study_id

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