Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer

Sponsor

Northwestern University (Other)

Overall Status

Terminated

CT.gov ID

NCT01060514

Collaborator

Robert H. Lurie Cancer Center (Other)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Non Small Cell Lung Cancer Metastatic Breast Cancer	Drug: Pazopanib Drug: Vinorelbine	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pazopanib + Vinorelbine	Drug: Pazopanib dose escalation, administered orally, daily Drug: Vinorelbine dose escalation, IV days 1 and 8 of every cycle (cycles begin every 3 weeks) Other Names: Navelbine

Arm

Intervention/Treatment

Experimental: Pazopanib + Vinorelbine

Drug: Pazopanib

dose escalation, administered orally, daily

Drug: Vinorelbine

dose escalation, IV days 1 and 8 of every cycle (cycles begin every 3 weeks)

Other Names:

Navelbine

Outcome Measures

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. [at study completion (estimated at 2 years)]

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. [imaging done every 6 weeks]
To characterize dose limiting toxicities (DLT). [labs drawn weekly]
To determine the pharmacokinetic effect of pazopanib on vinorelbine. [labs drawn on days 1 and 22]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.