|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00459862 |
Purpose
RATIONALE: Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: pazopanib hydrochloride Other: laboratory biomarker analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of GW786034 in Patients With Malignant Pleural Mesothelioma |
| Estimated Enrollment: | 55 |
| Study Start Date: | March 2007 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
Blood is collected at baseline and prior to each course of therapy and analyzed for markers of angiogenesis.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant pleural mesothelioma
No symptomatic, untreated, or uncontrolled CNS metastases
Patients with CNS metastases treated with whole brain radiation (WBRT) may be enrolled after completion of WBRT
PATIENT CHARACTERISTICS:
No condition that impairs ability to swallow and retain study drug tablets including, but not limited to, any of the following:
No other primary malignancy except for carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
None of the following concurrent severe and/or uncontrolled medical conditions:
No cardiovascular illness or complication, including any of the following:
NYHA class III-IV heart failure
PRIOR CONCURRENT THERAPY:
Prior palliative radiotherapy allowed
No concurrent therapeutic warfarin
Contacts and Locations
Show 153 Study Locations| Study Chair: | Julian Molina, MD, PhD | Mayo Clinic |
| Investigator: | Nicholas F. Reuter, MD | Coborn Cancer Center |
More Information
| Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
| Study ID Numbers: | CDR0000539269, NCCTG-N0623 |
| Study First Received: | April 11, 2007 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00459862 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
advanced malignant mesothelioma localized malignant mesothelioma recurrent malignant mesothelioma |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Mesothelial |
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |