Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101283
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2005-01-07
Brief Title:
Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Pemetrexed Plus Gemcitabine Or Carboplatin In Patients With Advanced Malignant Mesothelioma A Randomized Phase II Trial
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 pemetrexed disodium gemcitabine 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 It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma
PURPOSE This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma
PURPOSE This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma
Detailed Description:
OBJECTIVES
Primary
Estimate the response rates in patients with advanced malignant mesothelioma of the pleura treated with pemetrexed disodium combined with either gemcitabine or carboplatin
Secondary
Assess the toxic effects of these regimens in these patients
Estimate survival time in patients treated with these regimens
Correlate smoking status with outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms While randomized the study is not a comparative study Rather outcomes on each arm will be compared to a historical control rate from previous studies Randomization allows simultaneous testing of two experimental arms
Arm I Patients receive intravenous IV pemetrexed disodium over 10 minutes and carboplatin IV over 30 minutes on day 1
Arm II Patients receive pemetrexed disodium as in arm I and gemcitabine IV over 30 minutes on days 1 and 8
In both arms treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Beginning approximately 5-10 days before the start of chemotherapy and continuing until approximately 3 weeks after completion of chemotherapy all patients receive oral folic acid once daily and cyanocobalamin vitamin B12 intramuscularly every 9 weeks
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 32-60 patients 16-30 per treatment arm will be accrued for this study within 128-270 months
Primary
Estimate the response rates in patients with advanced malignant mesothelioma of the pleura treated with pemetrexed disodium combined with either gemcitabine or carboplatin
Secondary
Assess the toxic effects of these regimens in these patients
Estimate survival time in patients treated with these regimens
Correlate smoking status with outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms While randomized the study is not a comparative study Rather outcomes on each arm will be compared to a historical control rate from previous studies Randomization allows simultaneous testing of two experimental arms
Arm I Patients receive intravenous IV pemetrexed disodium over 10 minutes and carboplatin IV over 30 minutes on day 1
Arm II Patients receive pemetrexed disodium as in arm I and gemcitabine IV over 30 minutes on days 1 and 8
In both arms treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Beginning approximately 5-10 days before the start of chemotherapy and continuing until approximately 3 weeks after completion of chemotherapy all patients receive oral folic acid once daily and cyanocobalamin vitamin B12 intramuscularly every 9 weeks
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 32-60 patients 16-30 per treatment arm will be accrued for this study within 128-270 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 |
|---|---|---|---|
| U10CA021115 | NIH | None | None |
| E1B03 | OTHER | None | None |
| E1B03 | OTHER | NCCTG | httpsreporternihgovquickSearchU10CA021115 |