Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00647426
First received: March 25, 2008
Last updated: September 23, 2016
Last verified: December 2011
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Purpose
This is an open-label, single institution, phase II study of Sorafenib in combination with docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib twice a day on the 1st day of treatment and continue to take the medication every day until progression of disease, prohibitive toxicity, or patient withdrawal from the study. Chemotherapy courses will repeat every 21 days in the absence of disease progression or unacceptable toxicity for a total of four cycles.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Sorafenib + Docetaxel/Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Sorafenib in Combination With Carboplatin and Docetaxel in the First Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:
Primary Outcome Measures:
- Estimate the objective response rate of patients with Stage IIIB/IV NSCLC receiving the combination therapy of Sorafenib and docetaxel/carboplatin [ Time Frame: Analysis occurs once last patient completes chemotherapy ]
Secondary Outcome Measures:
- To estimate the progression-free survival (PFS) and overall survival for all patients [ Time Frame: Once last patient completes chemotherapy ]
- To evaluate the toxicities of Sorafenib in patients with advanced and metastatic NSCLC [ Time Frame: Once the last patient has completed chemotherapy ]
- To measure surrogate biomarkers of Sorafenib activity and toxicity [ Time Frame: Once the last patient has completed chemotherapy ]
| Enrollment: | 7 |
| Study Start Date: | November 2007 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle
|
Drug: Sorafenib + Docetaxel/Carboplatin
400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed NSCLC with clinical or radiological evidence of advanced disease (Stage IIIB/IV)
- Uni-dimensionally measurable disease
- Age => 18 years
- ECOG performance status of 0-1
- Life expectancy > 3 months
Exclusion Criteria:
- Small-cell or mixed histologies including a small cell component
- Prior chemotherapy, biotherapy, radiotherapy to an area of measurable disease
- Patients with peripheral neuropathy grade => 2
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647426
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647426
Locations
| United States, Pennsylvania | |
| Abramson Cancer Center of University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
More Information
| Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00647426 History of Changes |
| Other Study ID Numbers: |
UPCC 12506 |
| Study First Received: | March 25, 2008 |
| Last Updated: | September 23, 2016 |
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
|
Stage IIIB/IV |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Sorafenib Docetaxel Carboplatin |
Niacinamide Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on May 25, 2017