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

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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Breast Cancer; Metastatic Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Pazopanib; Drug: Vinorelbine

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Northwestern Medical Faculty Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Robert H. Lurie Cancer Center
• Investigators: Principal Investigator: Jyoti D Patel, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 29, 2010
• First Submitted That Met QC Criteria: February 1, 2010
• First Posted (Estimate): February 2, 2010

Study Record Updates

• Last Update Posted (Estimate): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 28, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Breast cancer; Lung cancer
• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Breast Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine
• Other Study ID Numbers: NU 09L1; STU00019948 (Other Identifier: Northwestern University IRB); NCI-2010-01850 (Other Identifier: NCI CTRP#)