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

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:	Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Docetaxel Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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


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
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations


United States, Pennsylvania
Abramson Cancer Center of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

More Information

No publications provided


Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00647426 History of Changes
Other Study ID Numbers:	UPCC 12506
Study First Received:	March 25, 2008
Last Updated:	January 31, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:


Stage IIIB/IV

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Carboplatin	Docetaxel Sorafenib Antimitotic Agents Antineoplastic Agents Enzyme Inhibitors Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Therapeutic Uses Tubulin Modulators

ClinicalTrials.gov processed this record on February 27, 2015