Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011921
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2001-03-03
Brief Title:
Chemotherapy Followed by Peripheral Stem Cell or Bone Marrow Transplant Compared With Chemotherapy Alone in Treating Patients With Small Cell Lung Cancer
Sponsor:
EBMT Solid Tumors Working Party
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Trial of Sequential High-Dose Chemotherapy Versus Standard Chemotherapy for the Treatment of Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 use different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy with peripheral stem cell transplant or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells It is not yet known whether high-dose chemotherapy plus peripheral stem cell or bone marrow transplant is more effective than chemotherapy alone in treating small cell lung cancer
PURPOSE This randomized phase III trial is studying how well chemotherapy followed by peripheral stem cell or bone marrow transplant works compared to chemotherapy alone in treating patients with limited-stage or extensive-stage small cell lung cancer
PURPOSE This randomized phase III trial is studying how well chemotherapy followed by peripheral stem cell or bone marrow transplant works compared to chemotherapy alone in treating patients with limited-stage or extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with limited or extensive stage small cell lung cancer treated with sequential high-dose ifosfamide carboplatin and etoposide phosphate followed by autologous peripheral blood stem cell or bone marrow transplantation versus standard ifosfamide carboplatin and etoposide
Compare the progression-free survival time to treatment failure and response rate in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage limited disease vs extensive disease with vs without liver metastases performance status 0 vs 1 gender LDH level normal vs abnormal and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction therapy comprising epirubicin IV over 4 hours on day 1 and paclitaxel IV over 3 hours on day 2 Treatment repeats every 21 days for a total of 2 courses Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 3 and continuing for 10 days or during course 2 until peripheral blood stem cell PBSC collection is completed After completion of induction chemotherapy autologous PBSCs or bone marrow is collected
Within 28 days of the start of the second course of induction chemotherapy patients receive high-dose ifosfamide IV over 17 hours carboplatin IV over 3 hours and etoposide phosphate IV over 3 hours on days 1-4 At 48 hours after completion of high-dose chemotherapy patients undergo autologous PBSC or bone marrow transplantation and then receive G-CSF SC for 14 days Treatment repeats every 28 days for 3 courses
Arm II Patients receive ifosfamide IV continuously over 24 hours carboplatin IV over 1 hour on day 1 and etoposide IV over 45 minutes on days 1 and 2 Treatment repeats every 28 days for 6 courses
After completion of high-dose or standard chemotherapy patients with limited disease or extensive disease in complete remission receive thoracic radiotherapy daily on days 1-5 for 6 weeks All patients in complete remission receive prophylactic cranial radiotherapy daily on days 1-5 for 3 weeks
Quality of life is assessed at baseline at the beginning of courses 1 and 3 high-dose chemotherapy or courses 3 and 5 standard chemotherapy and then at 7 12 and 18 months
Patients are followed monthly
PROJECTED ACCRUAL A total of 430 patients 215 per treatment arm will be accrued for this study within 3 years
Compare the overall survival of patients with limited or extensive stage small cell lung cancer treated with sequential high-dose ifosfamide carboplatin and etoposide phosphate followed by autologous peripheral blood stem cell or bone marrow transplantation versus standard ifosfamide carboplatin and etoposide
Compare the progression-free survival time to treatment failure and response rate in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage limited disease vs extensive disease with vs without liver metastases performance status 0 vs 1 gender LDH level normal vs abnormal and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive induction therapy comprising epirubicin IV over 4 hours on day 1 and paclitaxel IV over 3 hours on day 2 Treatment repeats every 21 days for a total of 2 courses Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 3 and continuing for 10 days or during course 2 until peripheral blood stem cell PBSC collection is completed After completion of induction chemotherapy autologous PBSCs or bone marrow is collected
Within 28 days of the start of the second course of induction chemotherapy patients receive high-dose ifosfamide IV over 17 hours carboplatin IV over 3 hours and etoposide phosphate IV over 3 hours on days 1-4 At 48 hours after completion of high-dose chemotherapy patients undergo autologous PBSC or bone marrow transplantation and then receive G-CSF SC for 14 days Treatment repeats every 28 days for 3 courses
Arm II Patients receive ifosfamide IV continuously over 24 hours carboplatin IV over 1 hour on day 1 and etoposide IV over 45 minutes on days 1 and 2 Treatment repeats every 28 days for 6 courses
After completion of high-dose or standard chemotherapy patients with limited disease or extensive disease in complete remission receive thoracic radiotherapy daily on days 1-5 for 6 weeks All patients in complete remission receive prophylactic cranial radiotherapy daily on days 1-5 for 3 weeks
Quality of life is assessed at baseline at the beginning of courses 1 and 3 high-dose chemotherapy or courses 3 and 5 standard chemotherapy and then at 7 12 and 18 months
Patients are followed monthly
PROJECTED ACCRUAL A total of 430 patients 215 per treatment arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V01-1645 | None | None | None |
| EBMT-RANDOM-ICE | None | None | None |
| EU-98001 | None | None | None |