Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00378573 |
This is a Phase II prospective, multicenter study evaluating Progression Free Survival ("PFS") after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in subjects with advanced or metastatic NSCLC. PFS will be measured from the date of registration (ie, assignment of subject number when subject meets all entry criteria) to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first.
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Drug: docetaxel Drug: gemcitabine Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
Enrollment: | 17 |
Study Start Date: | August 2006 |
Study Completion Date: | May 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
INCLUSION CRITERIA:
Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as
EXCLUSION CRITERIA:
Responsible Party: | sanofi-aventis ( Study Director ) |
Study ID Numbers: | DOCET_L_00730 |
Study First Received: | September 19, 2006 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00378573 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Antimetabolites Immunologic Factors Bevacizumab Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Carcinoma Docetaxel |
Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Docetaxel Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Growth Inhibitors |
Angiogenesis Modulating Agents Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung |