Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01179269
• Other study ID #: 202499
• Status: Withdrawn
• Phase: Phase 2
• First received: August 6, 2010
• Last updated: October 10, 2016
• Start date: March 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2016
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Lung cancer is the leading cause of cancer worldwide with approximately 1.2 million new cases each year. Non-small cell lung cancer (NSCLC) accounts for greater than 80% of all lung carcinomas in Western countries. Surgical resection is the treatment of choice for patients with early stage disease (Stage I and II), but at least 50% of these patients will relapse locally and/or develop distant metastases. Furthermore, 70% of patients with NSCLC are non-resectable at the time of their diagnosis due to either locally advanced or metastatic disease. The long-term prognosis for patients with NSCLC remains poor with the overall 5-year survival rate less than 15%. The low survival rate may be attributed to the high incidence of unresectable disease at presentation and the inability of systemic therapy to cure metastatic disease. There is a clear need for improvement in the treatment of NSCLC.

Description:

The primary objective of this study is to evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1). A subject is defined as a responder if he/she sustains a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during treatment. A subject without a post-baseline assessment of response will be considered a non-responder.

A secondary objective of this study is to evaluate the safety and tolerability of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), exposure, withdrawals due to AEs, dose reductions or interruptions, and changes from baseline in vital signs and clinical laboratory parameters.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed malignant pleural effusion) or Stage IV NSCLC.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• No prior systemic first-line therapy for Stage IIIB/IV NSCLC with chemotherapy or any other biologic therapy. Prior surgery and/or localized irradiation for NSCLC are permitted. Palliative radiation therapy must have ended 14 days prior to first dose of pazopanib. Subject with recurrence after previous NSCLC that has been treated with surgery with or without adjuvant chemotherapy/radiation for curative intent are eligible, provided 12 months have passed since this treatment ended.

Exclusion Criteria:

• Appropriate for doublet therapy as first line therapy. At discretion of investigator.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Pazopanib plus Paclitaxel
Pazopanib daily and weekly paclitaxel IV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate of pazopanib in combination with paclitaxel	The count of individuals who sustain a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during two years of treatment will be reported. A CR or PR response will be defined using standard RECIST criteria (version 1.1).	2 years	No