Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Northwestern University
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: April 17, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2014 (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: | April 17, 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 May 23, 2013