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Phase I Safety and Tolerability Study of Cediranib (RECENTIN™, AZD2171) in Combination With Chemo in First Line Lung Cancer Patients

NCT ID: NCT00621361

Last Updated: 2012-12-17

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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-02-29

Brief Summary

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This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.

Detailed Description

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Conditions

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Lung Cancer

Keywords

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Lung Cancer AZD2171 cediranib RECENTIN etoposide cisplatin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD2171

Intervention Type DRUG

Oral

2

Etoposide + Cisplatin

Group Type ACTIVE_COMPARATOR

Etoposide

Intervention Type DRUG

Intravenous

Cisplatin

Intervention Type DRUG

Intravenous

Interventions

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AZD2171

Oral

Intervention Type DRUG

Etoposide

Intravenous

Intervention Type DRUG

Cisplatin

Intravenous

Intervention Type DRUG

Other Intervention Names

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Recentin™ Etopophos® Platinol

Eligibility Criteria

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Inclusion Criteria

* Cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which EP would be considered a standard therapy, required at the time of diagnosis.)
* No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.)
* WHO performance status 0-2

Exclusion Criteria

* Untreated unstable brain or meningeal metastases
* Patient with inappropriate laboratory tests values
* Inadequate bone marrow reserve.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Heymach, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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Research Site

Sacramento, California, United States

Site Status

Research Site

Denver, Colorado, United States

Site Status

Research Site

Kansas City, Kansas, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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D8480C00054

Identifier Type: -

Identifier Source: org_study_id