Phase I FOLFOX Combination

NCT ID: NCT00499850

Last Updated: 2016-08-25

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-04-30

Brief Summary

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A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.

Detailed Description

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Conditions

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Advanced Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ZD6474 (vandetanib)

once daily oral dose

Intervention Type DRUG

5-Fluorouracil

intravenous infusion

Intervention Type DRUG

Leucovorin

intravenous infusion

Intervention Type DRUG

Oxaliplatin

intravenous infusion

Intervention Type DRUG

Other Intervention Names

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ZACTIMAâ„¢ 5-FU

Eligibility Criteria

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Inclusion Criteria

1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV)
2. WHO performance status 0-1
3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques

Exclusion Criteria

1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
3. prior unanticipated severe reaction to oxaliplatin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Research Site

East Melbourne, , Australia

Site Status

Research Site

Footscray, , Australia

Site Status

Research Site

Heidelberg, , Australia

Site Status

Research Site

Parkville, , Australia

Site Status

Countries

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Australia

Other Identifiers

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D4200C00037

Identifier Type: -

Identifier Source: org_study_id

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