Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062010
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2003-06-05
Brief Title:
Interferon Alfa Isotretinoin and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Interferon Alpha NSC 377523 Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 Drugs used in chemotherapy such as paclitaxel work in different ways to stop tumor cells from dividing so they stop growing or die Some tumors become resistant to chemotherapy drugs Giving interferon alfa and isotretinoin together with paclitaxel may reduce resistance to the drug and allow the tumor cells to be killed
PURPOSE This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer
PURPOSE This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the frequency and duration of response in patients with recurrent small cell lung cancer treated with interferon alfa isotretinoin and paclitaxel
Determine the toxic effects of this regimen in these patients
Determine the duration of survival in patients treated with this regimen
Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive interferon alfa subcutaneously and oral isotretinoin on days 1 and 2 and paclitaxel IV over 1 hour on day 2 of weeks 1-6 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 37-83 patients will be accrued for this study
Determine the frequency and duration of response in patients with recurrent small cell lung cancer treated with interferon alfa isotretinoin and paclitaxel
Determine the toxic effects of this regimen in these patients
Determine the duration of survival in patients treated with this regimen
Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive interferon alfa subcutaneously and oral isotretinoin on days 1 and 2 and paclitaxel IV over 1 hour on day 2 of weeks 1-6 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 37-83 patients will be accrued for this study
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 |
|---|---|---|---|
| E6501 | OTHER | ECOG | None |