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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sorafenib + Docetaxel/Carboplatin
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Stage IIIB/IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sorafenib + Docetaxel/Carboplatin

Arm Description

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

Outcomes

Primary Outcome Measures

The Number of Patients With Stage IIIB/IV NSCLC Response Rate to the Combination Therapy of Sorafenib and Docetaxel/Carboplatin
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

Number of Participants the Progression-free Survival (PFS) .
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
Number of Participants With Serious Adverse Events
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: Death Life-threatening Persistent or significant disability/incapacity In patient hospitalization or prolongation of existing hospitalization 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
The Number of Participants With Biomarkers of Sorafenib Activity and Toxicity
Monitored at designated timepoints.All patients will be evaluable for toxicity from the time of their first treatment with SORAFENIB.

Full Information

First Posted
March 25, 2008
Last Updated
September 30, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00647426
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Stage IIIB/IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sorafenib + Docetaxel/Carboplatin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sorafenib + Docetaxel/Carboplatin
Other Intervention Name(s)
Carboplatin: Paraplatin, CBDCA
Intervention Description
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
Primary Outcome Measure Information:
Title
The Number of Patients With Stage IIIB/IV NSCLC Response Rate to the Combination Therapy of Sorafenib and Docetaxel/Carboplatin
Description
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.
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Number of Participants the Progression-free Survival (PFS) .
Description
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
Time Frame
30 months
Title
Number of Participants With Serious Adverse Events
Description
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: Death Life-threatening Persistent or significant disability/incapacity In patient hospitalization or prolongation of existing hospitalization 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
Time Frame
30 months
Title
The Number of Participants With Biomarkers of Sorafenib Activity and Toxicity
Description
Monitored at designated timepoints.All patients will be evaluable for toxicity from the time of their first treatment with SORAFENIB.
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracey Evans, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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