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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00316433
First Posted: April 20, 2006
Last Update Posted: April 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi-Synthelabo
Information provided by:
Swedish Medical Center
  Purpose
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.

Condition Intervention Phase
Small Cell Lung Cancer Drug: Irinotecan (CPT-11) Drug: Oxaliplatin (Eloxatin) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin and CPT-11 as First Line Treatment for Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Estimated Enrollment: 24
Study Start Date: February 2005
Study Completion Date: January 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316433


Locations
United States, Washington
Swedish Medical Center Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Sanofi-Synthelabo
Investigators
Principal Investigator: Howard (Jack) West, MD Swedish Medical Center Cancer Institute
  More Information

ClinicalTrials.gov Identifier: NCT00316433     History of Changes
Other Study ID Numbers: OX-03-099
First Submitted: April 18, 2006
First Posted: April 20, 2006
Last Update Posted: April 5, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Oxaliplatin
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action