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

NCT ID: NCT01060514

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Metastatic Non Small Cell Lung Cancer Metastatic Breast Cancer

Keywords

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Lung cancer Breast cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pazopanib + Vinorelbine

Group Type EXPERIMENTAL

Pazopanib

Intervention Type DRUG

dose escalation, administered orally, daily

Vinorelbine

Intervention Type DRUG

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

Interventions

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Pazopanib

dose escalation, administered orally, daily

Intervention Type DRUG

Vinorelbine

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

Intervention Type DRUG

Other Intervention Names

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Navelbine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert H. Lurie Cancer Center

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Jyoti Patel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jyoti D Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University, Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00019948

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2010-01850

Identifier Type: OTHER

Identifier Source: secondary_id

NU 09L1

Identifier Type: -

Identifier Source: org_study_id