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Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVTreatmentApproved-not yet active18 and overPharmaceutical / IndustryMC#08-002
IIT 12230, NCT00883675

Trial Description

Summary

The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.

Eligibility Criteria

Inclusion Criteria:

  • Non-small cell lung cancer stage IB - IIIA, complete resection with mediastinal lymph node dissection
  • ECOG status 0-1
  • >14 and <56 days since resection

Exclusion Criteria:

  • Prior chemotherapy and/or radiation therapy for lung cancer
  • Peripheral neuropathy > grade 1
  • Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Medical condition that will not permit treatment or follow up according to the protocol
  • Prior treatment with docetaxel or carboplatin
  • Hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol
  • Treatment with other investigational anti-cancer drugs within 30 days of registration
  • Pregnant or nursing women
  • HIV-positive patients

Trial Contact Information

Trial Lead Organizations/Sponsors

Maestro Clinical, Inc.

Sanofi-Aventis - US - Bridgewater

David M. JablonsPrincipal Investigator

David M. JablonsPh: 415-353-7502
  Email: jablonsd@ucsfmedctr.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00883675
Information obtained from ClinicalTrials.gov on April 20, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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