Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab (LCCC0921)
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Purpose
This is an open label Phase II Trial that using the investigational anti-cancer agent, Pazopanib to see whether non-squamous non-small cell lung cancer will respond to its use by decreasing the size of the tumor or stopping its growth.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Pazopanib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center Open Label Phase II Study of Pazopanib in Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer After Progression on First Line Therapy Containing Bevacizumab |
- Best overall response and progression free survival [ Time Frame: Eight (8) months w additional time for response date to mature ] [ Designated as safety issue: Yes ]CR + PR + SD equal to or greater than 12 weeks that will evalute the activity of pazopanib alone in patients with stage IIIB/IV non-squamous NSCLC who have progressed on first line therapy containing bevacizumab
- Estimate combined response rate CR + PF of pazopanib according to RECIST [ Time Frame: 8 months with additional time for response to mature ] [ Designated as safety issue: No ]To estimate the progression free survival (time of enrollment until disease progression or death) and overall survival from time of enrollment to death. To evaluate the safety and tolerability of pazopanib using the NCI CTCAE version 4.0 To explore potential correlations betweel blood biomarkers and clinical response
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
-
Drug: Pazopanib
This multi-centered phase II trial will examine pazopanib stage IIIB/IV non-squamous NSCLC patients who have progressed on first-line therapy containing bevacizumab. Treatment should continue until disease progression, unacceptable toxicity, study withdrawal, or death. Patients who progress will be treated at the discretion of their physician. all patients who initiate treatment will be evaluated for disease control rate, which is the primary endpoint of this study.
The primary objective is to estimate the disease control rate of pazopanib alone in patients with stage IIIB/IV non-squamous NSCLC who progressed while on bevacizumab. Disease control rate id defined as complete (CR) + partial response (PR) + stable disease (SD) lasting greater than or equal to 12 weeks as defined by RECIST.
Secondary Objectives To estimate the combined response rate (CR + PR) of pazopanib according to RECIST To estimate the progression free survival (defined as time of enrollment until disease progression or death) and overall survival (defined as time of enrollment until death) of patients treated with pazopanib.
To evaluate the safety and tolerability of pazopanib using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0 To explore potential correlations between blood biomarkers and clinical response.
Pazopanib is dosed continuously throughout the study. Cycle lengths are identified as 21 days for purposes of the calendar.
The treatment dosage and administration for participating subjects will be, Pazopanib, 800 mg by mouth daily during a 21 day cycle until disease progression.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 or older
- Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph node involvement) or stage IV NSCLC
- Evidence of progression while on bevacizumab
- Patients treated for CNS metastases who are asymptomatic with no requirement for steroids for 2 weeks prior to first dose of study drug
Exclusion Criteria:
- Prior malignancy
- Clinically significant gastrointestinal abnormalities
- Presence of uncontrolled infection or nonhealing wound, fracture, or ulcer
- History of cardiovascular conditions within the past 6 months
Contacts and Locations| Contact: Donna Rowe, RN | (919) 966-7359 | donna_rowe@med.unc.edu |
| Contact: Diane Winans | (919) 843-2742 | diane_winans@med.unc.edu |
| United States, North Carolina | |
| North Carolina Cancer Hospital at U of North Carolina at CH | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Maureen Tynan, RN 919-966-4432 tynanm@med.unc.edu | |
| Contact: Honey Strickland, RN OCN 919-966-4432 honey_strickland@med.unc.edu | |
| Principal Investigator: Thomas E Stinchcombe, MD | |
| Sub-Investigator: Mark Socinski, MD | |
| Sub-Investigator: Juneko Grilley Olson, MD | |
| Rex Cancer Center at Rex Hospital | Recruiting |
| Raleigh, North Carolina, United States, 27607 | |
| Principal Investigator: JoEllen Speca, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Principal Investigator: Liza Villaruz, MD | |
| Principal Investigator: | Thomas Stinchcombe, MD | North Carolina Cancer Hospital at University of NC at Chapel Hill |
More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01262820 History of Changes |
| Obsolete Identifiers: | NCT01107652 |
| Other Study ID Numbers: | LCCC0921 |
| Study First Received: | December 7, 2010 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
Pazopanib Non Squamous Non Small Cell Lung Cancer After Progress on first line therapy Using Bevacizumab |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013