Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer

NCT01179269 | Withdrawn Phase 2 DMC

• 1 other identifier: 202499
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer; Pazopanib; Stage IIIB/IV non small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pazopanib plus Paclitaxel

EXPERIMENTAL

Pazopanib daily and weekly Paclitaxel IV.

Drug: Pazopanib plus Paclitaxel

Interventions

Pazopanib plus Paclitaxel DRUG

Pazopanib daily and weekly paclitaxel IV

Pazopanib plus Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Loyola University: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pazopanib; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Danielle Shafer, DO

  Loyola University

  PRINCIPAL INVESTIGATOR

• Cheryl Czerlanis, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 11, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share