Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pazopanib plus Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer, Pazopanib, Stage IIIB/IV non small cell lung cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed malignant pleural effusion) or Stage IV NSCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- No prior systemic first-line therapy for Stage IIIB/IV NSCLC with chemotherapy or any other biologic therapy. Prior surgery and/or localized irradiation for NSCLC are permitted. Palliative radiation therapy must have ended 14 days prior to first dose of pazopanib. Subject with recurrence after previous NSCLC that has been treated with surgery with or without adjuvant chemotherapy/radiation for curative intent are eligible, provided 12 months have passed since this treatment ended.
Exclusion Criteria:
- Appropriate for doublet therapy as first line therapy. At discretion of investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pazopanib plus Paclitaxel
Arm Description
Pazopanib daily and weekly Paclitaxel IV.
Outcomes
Primary Outcome Measures
Objective response rate of pazopanib in combination with paclitaxel
The count of individuals who sustain a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during two years of treatment will be reported. A CR or PR response will be defined using standard RECIST criteria (version 1.1).
Secondary Outcome Measures
Full Information
NCT ID
NCT01179269
First Posted
August 6, 2010
Last Updated
October 10, 2016
Sponsor
Loyola University
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01179269
Brief Title
Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer
Official Title
Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The study was stopped because the research team was unable to enroll any participants
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loyola University
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Lung cancer is the leading cause of cancer worldwide with approximately 1.2 million new cases each year. Non-small cell lung cancer (NSCLC) accounts for greater than 80% of all lung carcinomas in Western countries. Surgical resection is the treatment of choice for patients with early stage disease (Stage I and II), but at least 50% of these patients will relapse locally and/or develop distant metastases. Furthermore, 70% of patients with NSCLC are non-resectable at the time of their diagnosis due to either locally advanced or metastatic disease. The long-term prognosis for patients with NSCLC remains poor with the overall 5-year survival rate less than 15%. The low survival rate may be attributed to the high incidence of unresectable disease at presentation and the inability of systemic therapy to cure metastatic disease. There is a clear need for improvement in the treatment of NSCLC.
Detailed Description
The primary objective of this study is to evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1). A subject is defined as a responder if he/she sustains a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during treatment. A subject without a post-baseline assessment of response will be considered a non-responder.
A secondary objective of this study is to evaluate the safety and tolerability of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), exposure, withdrawals due to AEs, dose reductions or interruptions, and changes from baseline in vital signs and clinical laboratory parameters.
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
Non-small cell lung cancer, Pazopanib, Stage IIIB/IV non small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pazopanib plus Paclitaxel
Arm Type
Experimental
Arm Description
Pazopanib daily and weekly Paclitaxel IV.
Intervention Type
Drug
Intervention Name(s)
Pazopanib plus Paclitaxel
Intervention Description
Pazopanib daily and weekly paclitaxel IV
Primary Outcome Measure Information:
Title
Objective response rate of pazopanib in combination with paclitaxel
Description
The count of individuals who sustain a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during two years of treatment will be reported. A CR or PR response will be defined using standard RECIST criteria (version 1.1).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed malignant pleural effusion) or Stage IV NSCLC.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
No prior systemic first-line therapy for Stage IIIB/IV NSCLC with chemotherapy or any other biologic therapy. Prior surgery and/or localized irradiation for NSCLC are permitted. Palliative radiation therapy must have ended 14 days prior to first dose of pazopanib. Subject with recurrence after previous NSCLC that has been treated with surgery with or without adjuvant chemotherapy/radiation for curative intent are eligible, provided 12 months have passed since this treatment ended.
Exclusion Criteria:
Appropriate for doublet therapy as first line therapy. At discretion of investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Shafer, DO
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheryl Czerlanis, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer
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