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Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer

This study has been withdrawn prior to enrollment.
(The study was stopped because the research team was unable to enroll any participants)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT01179269
First received: August 6, 2010
Last updated: October 10, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Pazopanib plus Paclitaxel
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: Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Objective response rate of pazopanib in combination with paclitaxel [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Enrollment: 0
Study Start Date: March 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib plus Paclitaxel
Pazopanib daily and weekly Paclitaxel IV.
Drug: Pazopanib plus Paclitaxel
Pazopanib daily and weekly paclitaxel IV

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179269

Sponsors and Collaborators
Loyola University
GlaxoSmithKline
Investigators
Principal Investigator: Danielle Shafer, DO Loyola University
Principal Investigator: Cheryl Czerlanis, MD Loyola University
  More Information

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01179269     History of Changes
Other Study ID Numbers: 202499 
Study First Received: August 6, 2010
Last Updated: October 10, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Loyola University:
Non-small cell lung cancer
Pazopanib
Stage IIIB/IV non small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 07, 2016