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Sponsors and Collaborators: |
Penn State University Sanofi-Aventis |
Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00714246 |
This is a phase I/II study. The phase I portion of the study will determine the maximum tolerated dose of bortezomib when administered in combination with carboplatin & docetaxel and to determine the efficacy of the combination for patients with advanced NSCLC. Phase II will determine time to progression and overall survival and determine changes in serum proteomics patterns before & after combination therapy.
Condition | Intervention | Phase |
Non Small Cell Lung Cancer |
Drug: Docetaxel, Carboplatin, Bortezomib |
Phase I Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Carboplatin Docetaxel Bortezomib |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Phase I: Experimental |
Drug: Docetaxel, Carboplatin, Bortezomib
Patients will be enrolled to Phase 1 at the following dose levels: Level 1 - Carboplatin (day 1) 5 AUC mg/ml/min), Docetaxel (day 1) 60 mg/m2, Bortezomib (day 1,4,8,11) 0.7 mg/m2. Level 2A - Carboplatin (day 1) 6 AUC mg/ml/min), Docetaxel (day 1) 60 mg/m2, Bortezomib (day 1,4,8,11) 0.7 mg/m2. Level 2B - Carboplatin (day 1) 6 AUC mg/ml/min), Docetaxel (day 1) 60 mg/m2, Bortezomib (day 1,4,8,11) 1.0 mg/m2. Level 3 - Carboplatin (day 1) 6 AUC mg/ml/min), Docetaxel (day 1) 75 mg/m2, Bortezomib (day 1,4,8,11) 0.7 mg/m2. Level 4 - Carboplatin (day 1) 6 AUC mg/ml/min), Docetaxel (day 1) 75 mg/m2, Bortezomib (day 1,4,8,11) 1.0 mg/m2. Level 5 - Carboplatin (day 1) 6 AUC mg/ml/min), Docetaxel (day 1) 75 mg/m2, Bortezomib (day 1,4,8,11) 1.3 mg/m2
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Phase 2: Experimental |
Drug: Docetaxel, Carboplatin, Bortezomib
Phase II recommended dose is the highest dose level at which less than 2 patients (out of 6) experience dose limiting toxicity. A maximum of 4 cycles (1 cycle = 21 days) of chemotherapy will be administered to patients. Patients who demonstrate an ongoing response at the end of the 4th cycle of chemotherapy, may receive 2 more cycles of treatment.
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A chemotherapy efficacy plateau' has been reached for the treatment of patients with advanced or metastatic non-small cell lung cancer. Platinum-based two-drug combination is considered the current standard of care for the treatment of advanced NSCLC. There is a need to develop novel regimens to improve the outcome for patients with advanced NSCLC. The combination of carboplatin and docetaxel is effective for therapy of advanced NSCLC. This combination results in improved survival and quality of life for patients with advanced NSCLC. Docetaxel exhibits preclinical synergy with bortezomib. Hence we plan to perform a phase I/II study to define the maximum tolerated dose of bortezomib that can be administered in combination with docetaxel and carboplatin and subsequently evaluate the efficacy of the regimen for patients with advanced NSCLC.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chandra P Belani, MD | 717-531-1078 | cbelani@psu.edu |
Contact: Rebecca Miller, RN | 717-531-1003 | rmiller13@hmc.psu.edu |
United States, Pennsylvania | |||||
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Not yet recruiting | ||||
Hershey, Pennsylvania, United States, 17033 | |||||
Contact: Chandra P Belani, MD 717-531-1078 cbelani@psu.edu | |||||
Sub-Investigator: Salah Almokadem, MD |
Penn State University |
Sanofi-Aventis |
Principal Investigator: | Chandra P. Belani, MD | Penn State College of Medicine |
Responsible Party: | Penn State College of Medicine ( Chandra P. Belani, MD ) |
Study ID Numbers: | PSU 26983 |
First Received: | July 7, 2008 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00714246 |
Health Authority: | United States: Food and Drug Administration |
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