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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00647426
First received: March 25, 2008
Last updated: January 31, 2013
Last verified: December 2011
  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:


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

ClinicalTrials.gov processed this record on August 26, 2014