Back to resultsPazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer
Primary Purpose
Metastatic Non Small Cell Lung Cancer, Metastatic Breast Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pazopanib
Vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Non Small Cell Lung Cancer focused on measuring Lung cancer, Breast cancer
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Patients must have diagnosis of breast cancer or non small cell lung cancer
- Patients must have evaluable disease
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study.
- Patients must have given signed, informed consent prior to registration on study.
Exclusion Criteria:
- Patients must not be pregnant and/or lactating.
- Patients must not be receiving any other investigational agents.
- No prior exposure to vinorelbine or other VEGF inhibitors as treatment for metastatic disease
- Patients must not have received prior therapy (including radiation, surgery, and/or chemotherapy) within 30 days
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or vinorelbine.
- Patients cannot have received more than 2 prior chemotherapy regimens for lung cancer or 3 prior chemotherapy regimens for breast cancer. This criterion can be discussed further with the study doctor.
- Must not have uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmic, psychiatric illness/social situations that would limit compliance with study requirements.
Sites / Locations
- Northwestern University, Northwestern Medical Faculty Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pazopanib + Vinorelbine
Arm Description
Outcomes
Primary Outcome Measures
To determine the maximum tolerated dose (MTD), and the recommended Phase II dose to be used in patients with metastatic NSCLC and breast cancer.
Secondary Outcome Measures
To determine the response rate, progression free survival and overall survival in patients with metastatic NSCLC and metastatic breast cancer treated with pazopanib in combination with vinorelbine.
To characterize dose limiting toxicities (DLT).
To determine the pharmacokinetic effect of pazopanib on vinorelbine.
Full Information
NCT ID
NCT01060514
First Posted
January 29, 2010
Last Updated
October 28, 2013
Sponsor
Northwestern University
Collaborators
Robert H. Lurie Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01060514
Brief Title
Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer
Official Title
Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of timely accrual.
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Robert H. Lurie Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that can be given together without causing severe side effects. Also, this study will evaluate what effects (good and bad) that the treatment has on patients and their cancer.
Detailed Description
This study involves an investigational drug called pazopanib in combination with the chemotherapy drug vinorelbine. An investigational drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for use in the United States. Vinorelbine has been FDA approved to treat patients with NSCLC and breast cancer. Pazopanib is a vascular endothelial growth factor inhibitor, which means it may prevent the tumor from growing its own blood vessels thereby interfering with the growth of the tumor. Participants in this study will be assigned to one of three groups with each group receiving a higher dose of vinorelbine and pazopanib than the previous group. Vinorelbine will be given through a needle in the vein on days 1 and 8 of each 21 day study treatment cycle. Pazopanib is a pill which will be taken by mouth every day during the 21 day study treatment cycle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non Small Cell Lung Cancer, Metastatic Breast Cancer
Keywords
Lung cancer, Breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pazopanib + Vinorelbine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Intervention Description
dose escalation, administered orally, daily
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine
Intervention Description
dose escalation, IV days 1 and 8 of every cycle (cycles begin every 3 weeks)
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose (MTD), and the recommended Phase II dose to be used in patients with metastatic NSCLC and breast cancer.
Time Frame
at study completion (estimated at 2 years)
Secondary Outcome Measure Information:
Title
To determine the response rate, progression free survival and overall survival in patients with metastatic NSCLC and metastatic breast cancer treated with pazopanib in combination with vinorelbine.
Time Frame
imaging done every 6 weeks
Title
To characterize dose limiting toxicities (DLT).
Time Frame
labs drawn weekly
Title
To determine the pharmacokinetic effect of pazopanib on vinorelbine.
Time Frame
labs drawn on days 1 and 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Patients must have diagnosis of breast cancer or non small cell lung cancer
Patients must have evaluable disease
Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study.
Patients must have given signed, informed consent prior to registration on study.
Exclusion Criteria:
Patients must not be pregnant and/or lactating.
Patients must not be receiving any other investigational agents.
No prior exposure to vinorelbine or other VEGF inhibitors as treatment for metastatic disease
Patients must not have received prior therapy (including radiation, surgery, and/or chemotherapy) within 30 days
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or vinorelbine.
Patients cannot have received more than 2 prior chemotherapy regimens for lung cancer or 3 prior chemotherapy regimens for breast cancer. This criterion can be discussed further with the study doctor.
Must not have uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmic, psychiatric illness/social situations that would limit compliance with study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyoti D Patel, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University, Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer
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