Stage IIIB/IV Non-Small Cell Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2011 |
| End Date: | September 2015 |
| Contact: | Janice Dunne |
| Email: | jdunne@lumc.edu |
| Phone: | 708-327-3229 |
Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer
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.
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.
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.
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