Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
| City: |
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Birmingham |
| State: |
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Alabama |
| Zip Code: |
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35216 |
| Conditions: |
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Non-small Cell Lung Cancer |
| Purpose: |
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Tavocept is an investigational drug that is being developed to see if it can increase the
survival of patients who are being treated with chemotherapy as well as to see if it can
prevent or reduce side effects of chemotherapy. This research study is aimed at trying to
find out if people with advanced adenocarcinoma of the lung who are treated with a standard
combination of chemotherapy drugs will live longer if they are also treated with an
investigational drug called "Tavocept." Another objective of this research study is to find
out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage,
anemia, and nausea and vomiting that can occur with these drug combinations. The drug
combinations that will be used in this research study will include either paclitaxel and
cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to
treat people with advanced NSCLC. Every patient on this research study will be treated with
standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these
will be recommended by your research study doctor), which will be given in combination with
cisplatin.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Confirmed histopathological or cytological diagnosis of inoperable advanced primary
adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung
- No prior systemic treatment for non-small cell lung cancer including chemotherapy,
immunotherapy, hormonal therapy, targeted therapies or investigational drugs
Exclusion Criteria:
- Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg,
small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or
cytological diagnosis of primary lung cancer
- Adenocarcinoma arising from primary sites other than the lung
- Stage IIIB disease without malignant pleural or pericardial effusions or Stage I-IIIA
disease
- Patients with unstable CNS mets
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| NCT ID: |
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NCT00966914 |
| Primary Contact: |
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BioNumerik Clinical Study Coordinator
Phone: 210-614-1701
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| Backup Contact: |
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N/A |
| Location Contact: |
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Birmingham, Alabama 35216
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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