Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT00647426 |
Recruitment Status
:
Completed
First Posted
: March 31, 2008
Last Update Posted
: September 26, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: Sorafenib + Docetaxel/Carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647426
United States, Pennsylvania | |
Abramson Cancer Center of University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00647426 History of Changes |
Other Study ID Numbers: |
UPCC 12506 |
First Posted: | March 31, 2008 Key Record Dates |
Last Update Posted: | September 26, 2016 |
Last Verified: | December 2011 |
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 Docetaxel Sorafenib Carboplatin |
Niacinamide Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |