Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00647426
Recruitment Status : Completed
First Posted : March 31, 2008
Results First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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
Other Name: Carboplatin: Paraplatin, CBDCA




Primary Outcome Measures :
  1. The Number of Patients With Stage IIIB/IV NSCLC Response Rate to the Combination Therapy of Sorafenib and Docetaxel/Carboplatin [ Time Frame: 30 months ]

    The response rate from the combination therapy of Sorafenib and Docetaxel/carboplatin for patients with Stage IIIB/IV NSCLC.The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria (see section 9.3.1).Tumor Response: Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): a) At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

    Progressive Disease (PD): a) At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.



Secondary Outcome Measures :
  1. Number of Participants the Progression-free Survival (PFS) . [ Time Frame: 30 months ]
    Disease progression is based on RECIST documentation. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  2. Number of Participants With Serious Adverse Events [ Time Frame: 30 months ]

    Assessment of adverse events related to the combination infusion, These include a Serious Adverse Event (SAE) is an adverse event occurring at any dose that results in any of the following outcomes:

    1. Death
    2. Life-threatening
    3. Persistent or significant disability/incapacity
    4. In patient hospitalization or prolongation of existing hospitalization
    5. Congenital anomaly/birth defect or • blood dyscrasia without inpatient hospitalization

      • convulsions without inpatient hospitalization
      • intensive treatment in an emergency room or at home for allergic bronchospasm without inpatient hospitalization
      • development of drug dependency
      • drug abuse
      • overdose with an associated serious event, or required intervention to prevent impairment/damage

  3. The Number of Participants With Biomarkers of Sorafenib Activity and Toxicity [ Time Frame: 30 months ]
    Monitored at designated timepoints.All patients will be evaluable for toxicity from the time of their first treatment with SORAFENIB.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647426


Locations
Layout table for location information
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
Investigators
Layout table for investigator information
Principal Investigator: Tracey Evans, MD University of Pennsylvania

Layout table for additonal 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    Key Record Dates
Results First Posted: October 22, 2019
Last Update Posted: October 22, 2019
Last Verified: September 2019
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Stage IIIB/IV
Additional relevant MeSH terms:
Layout table for 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
Carboplatin
Docetaxel
Sorafenib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors