Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
18 Years
N/A
Both
Metastatic Non Small Cell Lung Cancer, Metastatic Breast Cancer
Trial Information
Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the maximum tolerated dose (MTD), and the recommended Phase II dose to be used in patients with metastatic NSCLC and breast cancer.
Outcome Time Frame:
at study completion (estimated at 2 years)
Safety Issue:
Yes
Principal Investigator
Jyoti D Patel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northwestern University
Authority:
United States: Food and Drug Administration
Study ID:
NU 09L1
NCT ID:
NCT01060514
Start Date:
February 2010
Completion Date:
February 2015
Related Keywords:
- Metastatic Non Small Cell Lung Cancer
- Metastatic Breast Cancer
- Lung cancer
- Breast cancer
- Breast Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Northwestern University, Northwestern Medical Faculty Foundation | Chicago, Illinois 60611-3013 |
