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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01060514
Recruitment Status : Terminated (Lack of timely accrual.)
First Posted : February 2, 2010
Last Update Posted : October 30, 2013
Robert H. Lurie Cancer Center
Information provided by (Responsible Party):
Jyoti Patel, Northwestern University

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 Type : Interventional  (Clinical Trial)
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 : February 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Navelbine

Primary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD), and the recommended Phase II dose to be used in patients with metastatic NSCLC and breast cancer. [ Time Frame: at study completion (estimated at 2 years) ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: imaging done every 6 weeks ]
  2. To characterize dose limiting toxicities (DLT). [ Time Frame: labs drawn weekly ]
  3. To determine the pharmacokinetic effect of pazopanib on vinorelbine. [ Time Frame: labs drawn on days 1 and 22 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01060514

United States, Illinois
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Robert H. Lurie Cancer Center
Principal Investigator: Jyoti D Patel, MD Northwestern University

Responsible Party: Jyoti Patel, Principal Investigator, Northwestern University Identifier: NCT01060514     History of Changes
Other Study ID Numbers: NU 09L1
STU00019948 ( Other Identifier: Northwestern University IRB )
NCI-2010-01850 ( Other Identifier: NCI CTRP# )
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Jyoti Patel, Northwestern University:
Lung cancer
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action