Lung Cancer Clinical Trial
Official title:
Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Giving paclitaxel and carboplatin together with gefitinib may kill
more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and
carboplatin together with gefitinib and to see how well it works in treating patients with
Stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
- To determine the efficacy, in terms of overall response, and safety of paclitaxel and
carboplatin in combination with intermittent gefitinib in patients with advanced
nonsquamous non-small cell lung cancer.
Secondary
- Determine the disease-control rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this
regimen.
OUTLINE: Patients receive paclitaxel IV on day 1, carboplatin IV on day 2, and oral
gefitinib once daily on days 8-17. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity. After completion of 4 courses,
patients with complete response or partial response may continue maintenance therapy
comprising oral gefitinib once daily in the absence of disease progression or unacceptable
toxicity.
Patients complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline,
during study treatment, and after completion of study treatment for quality-of-life study.
After completion of study treatment, patients are followed every 2 months for 2 years and
then every 4 months thereafter.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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