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Oxaliplatin/CPT-11 for Extensive Stage Small Cell Lung Cancer

NCT ID: NCT00316433

Last Updated: 2007-04-05

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-01-31

Brief Summary

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The purpose of this study is to determine the safety and effectiveness of the combination of oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small cell lung cancer.

Detailed Description

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Irinotecan (CPT-11)

Intervention Type DRUG

Oxaliplatin (Eloxatin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previously untreated extensive small cell lung cancer
* No prior chemotherapy
* No prior radiotherapy except for the treatment of brain metastases

Exclusion Criteria

* Prior treatment for extensive stage small cell lung cancer
* Known hypersensitivity to any of the components of oxaliplatin or CPT-11
* Greater than grade 2 peripheral neuropathy
* Known HIV or Hepatitis B or C (active, previously treated or both)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi-Synthelabo

INDUSTRY

Sponsor Role collaborator

Swedish Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Howard (Jack) West, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center Cancer Institute

Locations

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Swedish Medical Center Cancer Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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OX-03-099

Identifier Type: -

Identifier Source: org_study_id