Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, 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 gemcitabine and cisplatin together with gefitinib before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with gefitinib works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
Drug: gemcitabine hydrochloride
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study With Gefitinib (Sequentially) Following Gemcitabine/Cisplatin as Induction Regimen for Patients With Stage IIIA N2 NSCLC|
- Complete response rate as measured by RECIST criteria prior to surgery [ Designated as safety issue: No ]
- Overall response rate as measured by RECIST criteria prior to surgery [ Designated as safety issue: No ]
- Toxicity as assessed by CTC [ Designated as safety issue: Yes ]
|Study Start Date:||December 2004|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
- Determine the therapeutic activity of neoadjuvant induction therapy comprising gemcitabine, cisplatin, and gefitinib in patients with stage IIIA non-small cell lung cancer undergoing surgery.
- Determine the safety profile of this regimen in these patients.
- Determine the stage downsizing and complete resectability rate in patients with no progressive disease who undergo surgery after treatment with this regimen.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive induction therapy comprising gemcitabine IV over 30 minutes on days 1, 8, 22, 29, 43, and 50; cisplatin IV over 3-6 hours on days 2, 23, and 44; and oral gefitinib once daily on days 51-79. Treatment continues in the absence of disease progression or unacceptable toxicity. Within 2-7 days after completion of induction therapy, patients with no progressive disease undergo tumor resection.
After completion of study treatment, patients are followed at least every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Study Chair:||Nico Van Zandwijk, MD, PhD||The Netherlands Cancer Institute|