Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Pharmatech Genentech Sanofi-Aventis |
---|---|
Information provided by: | Pharmatech |
ClinicalTrials.gov Identifier: | NCT00766246 |
This is a randomized, open-label, multicenter study in 160 patients in first line treatment and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV).
Condition | Intervention | Phase |
---|---|---|
Stage IIIB or IV Non-Small Cell Lung Cancer |
Drug: bevacizumab Drug: pemetrexed Drug: docetaxel Drug: carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab Plus Pemetrexed Versus Pemetrexed Alone as Second-Line Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer |
Estimated Enrollment: | 160 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | August 2013 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
First-line: Experimental
|
Drug: bevacizumab
15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line, maintenance, and second-line treatments
Drug: docetaxel
75 mg/m2 administered in 21-day cycles on day 1 of each cycle for first line treatment
Drug: carboplatin
AUC=6 administered in 21-day cycles on day 1 of each cycle for first-line treatment
|
Maintenance: Experimental
|
Drug: bevacizumab
15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line, maintenance, and second-line treatments
|
Second-Line Arm A: Active Comparator
|
Drug: bevacizumab
15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line, maintenance, and second-line treatments
Drug: pemetrexed
500 mg/m2 administered in 21-day cycles on day 1 of each cycle for second-line treatment
|
Second-Line Arm B: Active Comparator
|
Drug: pemetrexed
500 mg/m2 administered in 21-day cycles on day 1 of each cycle for second-line treatment
|
This phase II clinical trial will address the issues of bevacizumab treatment duration and treatment safety as first-line therapy for patients with non-squamous NSCLC. Following disease progression or treatment failure, the potential benefit of continued bevacizumab therapy will be tested by randomizing patients to two treatment arms, including second-line chemotherapy with or without further bevacizumab. It is hypothesized that continuation of bevacizumab with pemetrexed as second-line treatment following progression will result in improved clinical outcomes for patients with NSCLC.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function:
Exclusion Criteria:
History of serious systemic disease including:
Contact: Joel Aronoff | 720-917-7452 | joela@pharmatech.com |
Contact: Nikos Sophos | 720-917-7470 | nickolass@pharmatech.com |
Principal Investigator: | Chandra P Belani, MD | Penn State Milton S. Hershey Medical Center, Penn State College of Medicine, Penn State Hershey Cancer Institute |
Responsible Party: | Penn State Hershey Cancer Institute ( Chandra P. Belani, M.D./Principal Investigator ) |
Study ID Numbers: | PSHCI 08-009 |
Study First Received: | October 1, 2008 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00766246 History of Changes |
Health Authority: | United States: Institutional Review Board |
Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer Lung Cancer |
Antimetabolites Thoracic Neoplasms Bevacizumab Carboplatin Folic Acid Antagonists Angiogenesis Inhibitors Carcinoma Docetaxel |
Pemetrexed Folic Acid Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Docetaxel Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Carboplatin Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Pemetrexed Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |