Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062062
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2003-06-05
Brief Title:
Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
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
Secondary
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
Tertiary
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 17 years
Primary
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
Secondary
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
Tertiary
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 17 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000304453 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02535 | REGISTRY | None | None |