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

Metastatic Breast Cancer Clinical Trial

Official title:

Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01060514
• Other study ID #: NU 09L1
• Secondary ID: STU00019948NCI-2
• Status: Terminated
• Phase: Phase 1
• First received: January 29, 2010
• Last updated: October 28, 2013
• Start date: February 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Breast Cancer
• Metastatic Non Small Cell Lung Cancer

Intervention

Drug:
• Pazopanib
dose escalation, administered orally, daily
• Vinorelbine
dose escalation, IV days 1 and 8 of every cycle (cycles begin every 3 weeks)

Locations

Country	Name	City	State
United States	Northwestern University, Northwestern Medical Faculty Foundation	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Robert H. Lurie Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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	No
Secondary	To characterize dose limiting toxicities (DLT).		labs drawn weekly	Yes
Secondary	To determine the pharmacokinetic effect of pazopanib on vinorelbine.		labs drawn on days 1 and 22	No