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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate the objective response rate of patients with Stage IIIB/IV NSCLC receiving the combination therapy of Sorafenib and docetaxel/carboplatin

Outcome Time Frame:

Analysis occurs once last patient completes chemotherapy

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UPCC 12506

NCT ID:

NCT00647426

Start Date:

November 2007

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Stage IIIB/IV
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Abramson Cancer Center Of University of PennsylvaniaPhiladelphia, Pennsylvania  19104