Stage IIIB/IV Non-Small Cell Lung Cancer
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Purpose
The purpose of this study is to evaluate the response rate of pazopanib in combination with paclitaxel for untreated NSCLC patients who are not eligible for front-line therapy with a platinum doublet. This is not a minority population as the average age at diagnosis for NSCLC approximates 70. The elderly have been largely under-represented in many of the phase III NSCLC chemotherapy trials. Furthermore, the treatment of patients with performance status 2 remains controversial as they may be less likely to benefit and more likely to experience toxicity from a platinum doublet. This population has been excluded from many of the phase III combination chemotherapy protocols. The taxanes (paclitaxel and docetaxel) have demonstrated efficacy and tolerability in the treatment of advanced NSCLC. There is limited data combining an anti-angiogenesis agent with chemotherapy in the elderly and PS 2 population. By inhibiting VEGFR, PDGFR, and c-kit, pazopanib may stop or slow the rate of tumor growth and development. The combination of the two agents with minimal overlapping toxicity may afford additive anti-tumor effects.
| 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 |
- objective response rate of pazopanib in combination with paclitaxel [ Time Frame: an average of 2 years ] [ Designated as safety issue: No ]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 RECIST criteria (version 1.1).
| Estimated Enrollment: | 53 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2014 (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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed malignant pleural effusion) or Stage IV NSCLC.
- 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| Contact: Janice Dunne | 708-327-3229 | jdunne@lumc.edu |
| United States, Illinois | |
| Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60123 | |
| Contact: Janice Dunne 708-327-3229 jdunne@lumc.edu | |
| Contact: Ann Lau Clark 708-327-3221 alausch@lumc.edu | |
| Principal Investigator: Danielle Shafer, D.O. | |
| Sub-Investigator: Cheryl Czerlanis, M.D. | |
| Sub-Investigator: Kathy Albain, M.D. | |
More Information
No publications provided
| 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 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Loyola University:
|
non small cell lung cancer Pazopanib Stage IIIB/IV non small cell lung cancer |
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 |
Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013