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

This study has been terminated.
(Lack of timely accrual.)
Sponsor:
Collaborator:
Robert H. Lurie Cancer Center
Information provided by (Responsible Party):
Jyoti Patel, Northwestern University
ClinicalTrials.gov Identifier:
NCT01060514
First received: January 29, 2010
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Metastatic Non Small Cell Lung Cancer
Metastatic Breast Cancer
Drug: Pazopanib
Drug: Vinorelbine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

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. [ Time Frame: at study completion (estimated at 2 years) ] [ Designated as safety issue: Yes ]

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. [ Time Frame: imaging done every 6 weeks ] [ Designated as safety issue: No ]
  • To characterize dose limiting toxicities (DLT). [ Time Frame: labs drawn weekly ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetic effect of pazopanib on vinorelbine. [ Time Frame: labs drawn on days 1 and 22 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2010
Study Completion Date: September 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060514

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

No publications provided

Responsible Party: Jyoti Patel, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01060514     History of Changes
Other Study ID Numbers: NU 09L1, STU00019948, NCI-2010-01850
Study First Received: January 29, 2010
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Lung cancer
Breast cancer

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

ClinicalTrials.gov processed this record on April 15, 2014