Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with carboplatin and paclitaxel works in treating older patients with unresectable or metastatic non-small cell lung cancer.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients > or = 65 Years of Age|
- Progression status at 6 months [ Designated as safety issue: No ]
- Confirmed response rate (complete or partial response) [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Quality of life as assessed by the Lung Cancer Symptom scale [ Designated as safety issue: No ]
- Social support measure as assessed by the Lubben Social Network scale [ Designated as safety issue: No ]
- Epidermal growth factor receptor concentrations [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
- Determine the 6-month progression status of older patients with unresectable or metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin and paclitaxel.
- Determine the response rate in patients treated with these regimens.
- Determine the quality of life of patients treated with these regimens.
- Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR) concentrations predict response in patients treated with these regimens.
- Correlate the presence of social support for these patients with toxicity and efficacy of these regimens.
- Determine whether social support for these patients differs according to gender.
- Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy regimen for these patients.
- Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of prespecified germline and tumor genes, and plasma and urine proteomic patterns with response rate and time to progression of patients receiving treatment in group I.
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment groups as determined by their treating physician.
- Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Group II: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I.
Quality of life is assessed at baseline and after the completion of course 2.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be accrued for this study within 1.7 years.