Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: Sorafenib + Docetaxel/Carboplatin	Phase 2

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. To estimate the progression-free survival (PFS) and overall survival for all patients [ Time Frame: Once last patient completes chemotherapy ]
2. To evaluate the toxicities of Sorafenib in patients with advanced and metastatic NSCLC [ Time Frame: Once the last patient has completed chemotherapy ]
3. To measure surrogate biomarkers of Sorafenib activity and toxicity [ Time Frame: Once the last patient has completed chemotherapy ]

Eligibility Criteria

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	March 31, 2008
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