Clinical trial NCT00647426: Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Stage IIIB/IV
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2008-03-31
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Patients will be monitored after every two cycles (6 weeks) for tumor response, stability, or progression by radiographic imaging studies. The primary goal of this study is to determine the clinical response rate of this regimen in patients with advanced lung cancer. Secondary endpoints include time to progression, overall survival, and toxicity. Blood levels of ERK-phosphorylation, activated caspase 3, cyclin D1, anti -cIAP2, p-Akt, and Mcl1 activity will be measured at the beginning, middle and end of therapy to help identify predictors of drug response and toxicity during the first cycle of treatment.

Eligibility 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

Primary outcomes:
measure: The Number of Patients With Stage IIIB/IV NSCLC Response Rate to the Combination Therapy of Sorafenib and Docetaxel/Carboplatin
timeFrame: 30 months
Secondary outcomes:
measure: Number of Participants the Progression-free Survival (PFS) .
timeFrame: 30 months
measure: Number of Participants With Serious Adverse Events
timeFrame: 30 months
measure: The Number of Participants With Biomarkers of Sorafenib Activity and Toxicity
timeFrame: 30 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Tracey Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: