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Sponsors and Collaborators: |
Washington University School of Medicine Cell Therapeutics |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00352690 |
This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial.
Consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chemoradiation.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: paclitaxel poliglumex Drug: carboplatin Procedure: radiation therapy Drug: Xyotax |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer |
Enrollment: | 10 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | August 2009 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
one cohort of 6 patients and one expanded cohort of 6 at a dose level of 135 mg/m2 of paclitaxel poliglumex, and one cohort of 6 at a dose level of 175 mg/m2.
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Drug: paclitaxel poliglumex
135 mg/m2 intravenously over 10 minutes on day 1 of each 21-day cycle for a total of 2 cycles
Drug: carboplatin
Carboplatin AUC = 5** by IV over 30 minutes (note that carboplatin is calculated using actual (not ideal) body weight on day 1 of each 21-day cycle for a total of 2 cycles.
Procedure: radiation therapy
You will receive radiation therapy every day for about 6-7 weeks (for a total of 33 days on a Monday through Friday schedule.After your radiation treatment ends, you will take a 3-5 week break.
Drug: Xyotax
135 mg/m2 of paclitaxel poliglumex, and 175 mg/m2 if tolerated at lower dose.
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Non-surgical candidates
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior Therapy:
Required Initial Laboratory Values (must be submitted within 16 days prior to registration):
INR > 0.8 < 1.2*
Exclusion Criteria:
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Ramaswamy Govindan, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Ramaswamy Govindan, M.D. ) |
Study ID Numbers: | 05-1195 |
Study First Received: | July 14, 2006 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00352690 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Carboplatin Antimitotic Agents Carcinoma Respiratory Tract Diseases Lung Neoplasms Paclitaxel |
Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |