Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227565
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2005-09-26
Brief Title:
Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 pemetrexed disodium and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage small cell lung cancer
PURPOSE This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the complete and partial response rates in patients with previously untreated extensive-stage small cell lung cancer treated with pemetrexed disodium and carboplatin
Secondary
Determine the toxicity of this regimen in these patients
Determine preliminarily the survival of patients treated with this regimen
Determine preliminarily the response rate in patients 70 years and older treated with this regimen
Determine preliminarily the toxicity of this regimen in patients 70 years and older
OUTLINE This is a multicenter study Patients are stratified according to age 70 years vs 70 years
Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL Approximately 77 patients at least 46 who are 70 years of age and at least 24 who are 70 years of age will be accrued for this study within 20-26 months
Primary
Determine the complete and partial response rates in patients with previously untreated extensive-stage small cell lung cancer treated with pemetrexed disodium and carboplatin
Secondary
Determine the toxicity of this regimen in these patients
Determine preliminarily the survival of patients treated with this regimen
Determine preliminarily the response rate in patients 70 years and older treated with this regimen
Determine preliminarily the toxicity of this regimen in patients 70 years and older
OUTLINE This is a multicenter study Patients are stratified according to age 70 years vs 70 years
Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL Approximately 77 patients at least 46 who are 70 years of age and at least 24 who are 70 years of age will be accrued for this study within 20-26 months
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 |
|---|---|---|---|
| CDR0000442866 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02671 | REGISTRY | None | None |